Diana Mahoney

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

SAN ANTONIO – Partial fundoplication improves dysphagia and regurgitation symptom scores in patients undergoing laparoscopic Heller myotomy for esophageal achalasia, regardless of whether the fundus is laid over the anterior esophagus or wrapped around the back of it, a multicenter study has shown.

Previous studies have demonstrated that partial fundoplication minimizes the likelihood of developing gastroesophageal reflux disease (GERD), but none has systematically compared the risks and benefits associated with wrapping the gastric fundus anterior to the esophagus (Dor fundoplication) or posterior to the esophagus (Toupet fundoplication), Dr. Arthur Rawlings said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The type of fundoplication that should be performed is controversial, and currently determined by surgeon’s choice rather than scientific evidence," he said. "Some surgeons advocate the Dor because they say it’s less complicated to perform, [avoids] the need for complete posterior dissection, completely disrupt the posterior esophageal ligament, and does cover the exposed esophageal mucosa." On the other hand, he noted, "other surgeons advocate for a Toupet fundoplication because it keeps the edges of the myotomy separated and possibly provides better reflux control."

To compare symptom frequency and severity as well as physiological differences associated with the two procedures, Dr. Rawlings of Washington University, St. Louis, and his colleagues conducted a multicenter, prospective trial. In all, 85 patients undergoing laparoscopic Heller myotomy at five sites in 2003-2008 were randomized to the Dor or Toupet partial fundoplication. The investigators assessed symptomatic GERD scores based on a 5-point (0-4) Likert scale preoperatively and at 2-6 weeks, 6 months, and 12 months postoperatively. They also evaluated 24-hour pH testing at 6-12 months, calculating the percentage of total pH time less than 4 and a composite DeMeester pH score, he said.

Both groups had similar age, sex distribution, and illness characteristics. The researchers obtained 6- to 12-month pH studies for 24 of the 49 patients who were randomized to the Dor procedure and 19 of the 36 patients who were randomized to the Toupet procedure, Dr. Rawlings said. The results reported at the meeting represent those obtained for the patients for whom pH-testing results were available, he explained.

In both groups, dysphagia and regurgitation symptom frequency and severity scores improved substantially, compared with preoperative measures, Dr. Rawlings said. "Statistically significant improvements were observed in both groups for all but heartburn and chest pain measures," he noted. Specifically, in the Dor group, the preoperative solid dysphagia, heartburn, and regurgitation scores of 3.0, 1.5, and 2.8, respectively, improved to 1.3, 0.7, and 0.7 at 6 months, and the preoperative scores in the Toupet group of 3.1, 1.0, and 3.3 improved to 1.0, 0.3, and 0.1, respectively, he said.

There was no significant difference between the two groups with respect to DeMeester pH scores or the percentage of pH time less than 4, although abnormal acid reflux was experienced by 42% of the Dor patients and just 21% of the Toupet patients, said Dr. Rawlings. The difference between the median DeMeester pH scores at 6 months for the Dor (7.2) and Toupet (2.2) groups did not reach statistical significance, he said.

In a subgroup analysis of individuals with abnormal reflux scores regardless of fundoplication procedure, "the only thing that fell out as significant was heartburn frequency and severity," Dr. Rawlings stated.

The findings indicate that both the Dor and Toupet procedures following Heller myotomy produce comparable decreases in reflux symptoms and improvements in quality of life, according to Dr. Rawlings. The differences in pathological acid reflux between the two groups, though not statistically significant, "do support the use of pH testing following Heller myotomy for detecting abnormal esophageal acid exposure," he said.

This study was supported a SAGES research grant. Dr. Rawlings disclosed financial relationships with Lifecell Corp. and Cook Medical.

Testing for epidermal growth factor receptor mutations is an important step in the evalu­ation process for systemic ther­apy in patients with metastatic or recurrent non–small cell lung cancer according to up­dated recommendations issued by the American Society of Clinical Oncology and the Na­tional Comprehensive Cancer Network.

ASCO issued a provisional clinical opinion (PCO) that pa­tients with advanced non–small cell lung cancer (NSCLC) who are being considered for treat­ment with one of the tyrosine kinase inhibitors (TKIs) that tar­get the epidermal growth factor receptor (EGFR) should under­go EGFR-mutation testing. 

Oncologists have learned that NSCLC is “really a collection of genetically distinct diseases,” ASCO’s PCO panel cochair Dr. Vicki L. Keedy of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a press release. The goal is to “treat pa­tients with drugs that target the molecular drivers of their spe­cific tumors rather than using a one-size-fits-all approach.”

The NCCN earlier updated its clinical management guide­lines to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

The NCCN recommendation does not extend to patients with squamous cell lung cancer, because the incidence of EGFR mutation in this patient subgroup is less than 3.6%, Dr. David S. Ettinger said in March at the organization’s an­nual conference. 

Both groups based their endorse­ments on studies demonstrating that mutations in two regions of EGFR gene appear to predict tumor response to chemotherapy in general, and to TKIs specifically.

Among the research priorities that were identified by ASCO, Dr. Keedy not­ed the trials that are designed to discern whether first-line treatment with a TKI in EGFR mutation–negative patients de­lays chemotherapy or affects outcome; whether chemotherapy prior to TKI treatment in EGFR mutation–positive patients affects outcome; and whether there are clinically significant differences between erlotinib (Tarceva) and gefi­tinib (Iressa) among EGFR mutation–positive patients. 

The last question is of particular in­terest, because gefitinib is not Food and Drug Association approved outside a special program in the United States, whereas erlotinib is currently approved as second-line therapy, she said.

Dr. Ettinger, chair of the NCCN’s NSCLC guideline panel and professor of oncology at Johns Hopkins University in Baltimore, cited findings from the landmark IPASS (Iressa Pan-Asia Study) investigation that compared progres­sion-free and overall survival in 1,217 East Asian patients with advanced NSCLC that was treated with the gefi­tinib or standard carboplatin and paclitaxel chemotherapy. 

IPASS demonstrated that EGFR mu­tation strongly predicted a lower risk of progression on gefitinib vs. chemother­apy (hazard ratio, 0.48), whereas wild-type EGFR predicted a higher risk of progression on gefitinib relative to chemotherapy (HR, 2.85) (N. Engl. J. Med. 2009;361:947-57). 

Similarly, in a pooled analysis of clin­ical outcomes of NSCLC patients who were treated with erlotinib, EGFR mu­tations were associated with a median progression-free survival of 13.2 vs. 5.9 months (J. Cell. Mol. Med. 2010;14:51-69). Neither study demonstrated a dif­ference in overall survival among treated patients with and without EGFR muta­tions, Dr. Ettinger said.

The updated NCCN guidelines also state that the sequencing of KRAS (a G protein involved in the EGFR-related signal transmission) could be useful for the selection of patients as candidates for TKI therapy. The KRAS gene can harbor oncogenic mutations that may render a tumor resistant to EGFR-targeting agents, Dr. Ettinger explained, noting that studies have shown that a KRAS mu­tation in patients with NSCLC “confers a high level of resistance” to TKIs. 

Although the data – which primarily come from retrospective reviews with small sample sizes – are insufficient to make a determination about an associ­ation between KRAS mutation status and survival, he said, they are sufficient to warrant a category 2A recommen­dation for sequencing, as well as a rec­ommendation that patients with a known KRAS mutation should undergo first-line therapy with an agent other than a TKI.

Individuals who test negative for EGFR and KRAS should also be screened for a mutation of the anaplastic lym­phoma kinase (ALK) fusion gene, Dr. Et­tinger said. 

“Patients who screen positive may not benefit from EGFR TKIs, but they may be good candidates for an ALK-targeted therapy,” he said, noting that the inves­tigational ALK-tar­geting drug crizotinib, in par­ticular, has demon­strated positive results in early studies of NSCLC patients with echinoderm mi­crotubule-associat­ed proteinlike 4 (EML4)-ALK translocations (N. Engl. J. Med. 2010;363:1693-703).

With respect to first-line systemic ther­apy, patients with adenocarcinoma, large cell carcinoma, or NSCLC “not other­wise specified” who have an Eastern Co­operative Oncology Group/World Health Organization performance status grade of 0-4 and who test positive for the EGFR mutation prior to first-line thera­py should be treated with erlotinib, ac­cording to the NCCN guidelines. 

Alternatively, the guidelines state that gefitinib can be used in place of erlotinib “in areas of the world where it is avail­able.” 

For patients in whom the EGFR mu­tation is discovered during chemothera­py, the guidelines recommend either adding erlotinib to the current chemotherapy protocol or switching to erlotinib as maintenance treatment.

For patients whose EGFR status is negative or unknown, even in the pres­ence of clinical characteristics that might be suggestive of a mutation (for exam­ple, female, nonsmoker, Asian race), con­ventional chemotherapy is recommended, Dr. Ettinger said. 

In an editorial that accompanied ASCO’s PCO announcement, Dr. Paul A. Bunn Jr. and Dr. Robert C. Doebele of the University of Colorado Cancer Center in Aurora wrote that the grow­ing clinical importance of molecularly defined subgroups of adenocarcinoma signals a “new era of personalized med­icine for patients with advanced lung cancer, in which it will be imperative to match the specific mutations of a patient’s tumor with a specific therapy.” 

The implemen­tation of routine, simultaneous testing of multiple markers will likely be con­ducted on all patients prior to treat­ment initiation, regardless of clinical features, they stated, acknowledging certain procedural challenges, includ­ing obtaining adequate tumor materi­al at the time of diagnostic biopsy and developing testing platforms “that si­multaneously analyze for the presence of somatic mutations, gene fusions, or other genetic challenges.”

The updated NCCN Guidelines for NSCLC are posted at www.nccn.org. The ASCO PCO is posted at www.asco.org/ascov2/Practice+&+Guidelines/Guidelines/Provisional+Clinical+Opinion.

Dr. Ettinger has consultancy agree­ments with the a number of pharma­ceutical companies Dr. Keedy receives commercial research support from Ari­ad Pharmaceuticals, Ziopharm Oncolo­gy, and Amgen Oncology Therapeutics. Dr. Bunn has a consultant or advisory role with a number of pharmaceutical companies. Dr. Doebele disclosed re­search funding from Lilly, ImClone Sys­tems, and Pfizer.

Testing for epidermal growth factor receptor mutations is an important step in the evalu­ation process for systemic ther­apy in patients with metastatic or recurrent non–small cell lung cancer according to up­dated recommendations issued by the American Society of Clinical Oncology and the Na­tional Comprehensive Cancer Network.

ASCO issued a provisional clinical opinion (PCO) that pa­tients with advanced non–small cell lung cancer (NSCLC) who are being considered for treat­ment with one of the tyrosine kinase inhibitors (TKIs) that tar­get the epidermal growth factor receptor (EGFR) should under­go EGFR-mutation testing. 

Oncologists have learned that NSCLC is “really a collection of genetically distinct diseases,” ASCO’s PCO panel cochair Dr. Vicki L. Keedy of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a press release. The goal is to “treat pa­tients with drugs that target the molecular drivers of their spe­cific tumors rather than using a one-size-fits-all approach.”

The NCCN earlier updated its clinical management guide­lines to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

The NCCN recommendation does not extend to patients with squamous cell lung cancer, because the incidence of EGFR mutation in this patient subgroup is less than 3.6%, Dr. David S. Ettinger said in March at the organization’s an­nual conference. 

Both groups based their endorse­ments on studies demonstrating that mutations in two regions of EGFR gene appear to predict tumor response to chemotherapy in general, and to TKIs specifically.

Among the research priorities that were identified by ASCO, Dr. Keedy not­ed the trials that are designed to discern whether first-line treatment with a TKI in EGFR mutation–negative patients de­lays chemotherapy or affects outcome; whether chemotherapy prior to TKI treatment in EGFR mutation–positive patients affects outcome; and whether there are clinically significant differences between erlotinib (Tarceva) and gefi­tinib (Iressa) among EGFR mutation–positive patients. 

The last question is of particular in­terest, because gefitinib is not Food and Drug Association approved outside a special program in the United States, whereas erlotinib is currently approved as second-line therapy, she said.

Dr. Ettinger, chair of the NCCN’s NSCLC guideline panel and professor of oncology at Johns Hopkins University in Baltimore, cited findings from the landmark IPASS (Iressa Pan-Asia Study) investigation that compared progres­sion-free and overall survival in 1,217 East Asian patients with advanced NSCLC that was treated with the gefi­tinib or standard carboplatin and paclitaxel chemotherapy. 

IPASS demonstrated that EGFR mu­tation strongly predicted a lower risk of progression on gefitinib vs. chemother­apy (hazard ratio, 0.48), whereas wild-type EGFR predicted a higher risk of progression on gefitinib relative to chemotherapy (HR, 2.85) (N. Engl. J. Med. 2009;361:947-57). 

Similarly, in a pooled analysis of clin­ical outcomes of NSCLC patients who were treated with erlotinib, EGFR mu­tations were associated with a median progression-free survival of 13.2 vs. 5.9 months (J. Cell. Mol. Med. 2010;14:51-69). Neither study demonstrated a dif­ference in overall survival among treated patients with and without EGFR muta­tions, Dr. Ettinger said.

The updated NCCN guidelines also state that the sequencing of KRAS (a G protein involved in the EGFR-related signal transmission) could be useful for the selection of patients as candidates for TKI therapy. The KRAS gene can harbor oncogenic mutations that may render a tumor resistant to EGFR-targeting agents, Dr. Ettinger explained, noting that studies have shown that a KRAS mu­tation in patients with NSCLC “confers a high level of resistance” to TKIs. 

Although the data – which primarily come from retrospective reviews with small sample sizes – are insufficient to make a determination about an associ­ation between KRAS mutation status and survival, he said, they are sufficient to warrant a category 2A recommen­dation for sequencing, as well as a rec­ommendation that patients with a known KRAS mutation should undergo first-line therapy with an agent other than a TKI.

Individuals who test negative for EGFR and KRAS should also be screened for a mutation of the anaplastic lym­phoma kinase (ALK) fusion gene, Dr. Et­tinger said. 

“Patients who screen positive may not benefit from EGFR TKIs, but they may be good candidates for an ALK-targeted therapy,” he said, noting that the inves­tigational ALK-tar­geting drug crizotinib, in par­ticular, has demon­strated positive results in early studies of NSCLC patients with echinoderm mi­crotubule-associat­ed proteinlike 4 (EML4)-ALK translocations (N. Engl. J. Med. 2010;363:1693-703).

With respect to first-line systemic ther­apy, patients with adenocarcinoma, large cell carcinoma, or NSCLC “not other­wise specified” who have an Eastern Co­operative Oncology Group/World Health Organization performance status grade of 0-4 and who test positive for the EGFR mutation prior to first-line thera­py should be treated with erlotinib, ac­cording to the NCCN guidelines. 

Alternatively, the guidelines state that gefitinib can be used in place of erlotinib “in areas of the world where it is avail­able.” 

For patients in whom the EGFR mu­tation is discovered during chemothera­py, the guidelines recommend either adding erlotinib to the current chemotherapy protocol or switching to erlotinib as maintenance treatment.

For patients whose EGFR status is negative or unknown, even in the pres­ence of clinical characteristics that might be suggestive of a mutation (for exam­ple, female, nonsmoker, Asian race), con­ventional chemotherapy is recommended, Dr. Ettinger said. 

In an editorial that accompanied ASCO’s PCO announcement, Dr. Paul A. Bunn Jr. and Dr. Robert C. Doebele of the University of Colorado Cancer Center in Aurora wrote that the grow­ing clinical importance of molecularly defined subgroups of adenocarcinoma signals a “new era of personalized med­icine for patients with advanced lung cancer, in which it will be imperative to match the specific mutations of a patient’s tumor with a specific therapy.” 

The implemen­tation of routine, simultaneous testing of multiple markers will likely be con­ducted on all patients prior to treat­ment initiation, regardless of clinical features, they stated, acknowledging certain procedural challenges, includ­ing obtaining adequate tumor materi­al at the time of diagnostic biopsy and developing testing platforms “that si­multaneously analyze for the presence of somatic mutations, gene fusions, or other genetic challenges.”

The updated NCCN Guidelines for NSCLC are posted at www.nccn.org. The ASCO PCO is posted at www.asco.org/ascov2/Practice+&+Guidelines/Guidelines/Provisional+Clinical+Opinion.

Dr. Ettinger has consultancy agree­ments with the a number of pharma­ceutical companies Dr. Keedy receives commercial research support from Ari­ad Pharmaceuticals, Ziopharm Oncolo­gy, and Amgen Oncology Therapeutics. Dr. Bunn has a consultant or advisory role with a number of pharmaceutical companies. Dr. Doebele disclosed re­search funding from Lilly, ImClone Sys­tems, and Pfizer.

Testing for epidermal growth factor receptor mutations is an important step in the evalu­ation process for systemic ther­apy in patients with metastatic or recurrent non–small cell lung cancer according to up­dated recommendations issued by the American Society of Clinical Oncology and the Na­tional Comprehensive Cancer Network.

ASCO issued a provisional clinical opinion (PCO) that pa­tients with advanced non–small cell lung cancer (NSCLC) who are being considered for treat­ment with one of the tyrosine kinase inhibitors (TKIs) that tar­get the epidermal growth factor receptor (EGFR) should under­go EGFR-mutation testing. 

Oncologists have learned that NSCLC is “really a collection of genetically distinct diseases,” ASCO’s PCO panel cochair Dr. Vicki L. Keedy of Vanderbilt-Ingram Cancer Center in Nashville, Tenn., said in a press release. The goal is to “treat pa­tients with drugs that target the molecular drivers of their spe­cific tumors rather than using a one-size-fits-all approach.”

The NCCN earlier updated its clinical management guide­lines to include a category 1 recommendation that EGFR testing should be undertaken after histologic diagnosis of adenocarcinoma, large cell carcinoma, or undifferentiated carcinoma.

The NCCN recommendation does not extend to patients with squamous cell lung cancer, because the incidence of EGFR mutation in this patient subgroup is less than 3.6%, Dr. David S. Ettinger said in March at the organization’s an­nual conference. 

Both groups based their endorse­ments on studies demonstrating that mutations in two regions of EGFR gene appear to predict tumor response to chemotherapy in general, and to TKIs specifically.

Among the research priorities that were identified by ASCO, Dr. Keedy not­ed the trials that are designed to discern whether first-line treatment with a TKI in EGFR mutation–negative patients de­lays chemotherapy or affects outcome; whether chemotherapy prior to TKI treatment in EGFR mutation–positive patients affects outcome; and whether there are clinically significant differences between erlotinib (Tarceva) and gefi­tinib (Iressa) among EGFR mutation–positive patients. 

The last question is of particular in­terest, because gefitinib is not Food and Drug Association approved outside a special program in the United States, whereas erlotinib is currently approved as second-line therapy, she said.

Dr. Ettinger, chair of the NCCN’s NSCLC guideline panel and professor of oncology at Johns Hopkins University in Baltimore, cited findings from the landmark IPASS (Iressa Pan-Asia Study) investigation that compared progres­sion-free and overall survival in 1,217 East Asian patients with advanced NSCLC that was treated with the gefi­tinib or standard carboplatin and paclitaxel chemotherapy. 

IPASS demonstrated that EGFR mu­tation strongly predicted a lower risk of progression on gefitinib vs. chemother­apy (hazard ratio, 0.48), whereas wild-type EGFR predicted a higher risk of progression on gefitinib relative to chemotherapy (HR, 2.85) (N. Engl. J. Med. 2009;361:947-57). 

Similarly, in a pooled analysis of clin­ical outcomes of NSCLC patients who were treated with erlotinib, EGFR mu­tations were associated with a median progression-free survival of 13.2 vs. 5.9 months (J. Cell. Mol. Med. 2010;14:51-69). Neither study demonstrated a dif­ference in overall survival among treated patients with and without EGFR muta­tions, Dr. Ettinger said.

The updated NCCN guidelines also state that the sequencing of KRAS (a G protein involved in the EGFR-related signal transmission) could be useful for the selection of patients as candidates for TKI therapy. The KRAS gene can harbor oncogenic mutations that may render a tumor resistant to EGFR-targeting agents, Dr. Ettinger explained, noting that studies have shown that a KRAS mu­tation in patients with NSCLC “confers a high level of resistance” to TKIs. 

Although the data – which primarily come from retrospective reviews with small sample sizes – are insufficient to make a determination about an associ­ation between KRAS mutation status and survival, he said, they are sufficient to warrant a category 2A recommen­dation for sequencing, as well as a rec­ommendation that patients with a known KRAS mutation should undergo first-line therapy with an agent other than a TKI.

Individuals who test negative for EGFR and KRAS should also be screened for a mutation of the anaplastic lym­phoma kinase (ALK) fusion gene, Dr. Et­tinger said. 

“Patients who screen positive may not benefit from EGFR TKIs, but they may be good candidates for an ALK-targeted therapy,” he said, noting that the inves­tigational ALK-tar­geting drug crizotinib, in par­ticular, has demon­strated positive results in early studies of NSCLC patients with echinoderm mi­crotubule-associat­ed proteinlike 4 (EML4)-ALK translocations (N. Engl. J. Med. 2010;363:1693-703).

With respect to first-line systemic ther­apy, patients with adenocarcinoma, large cell carcinoma, or NSCLC “not other­wise specified” who have an Eastern Co­operative Oncology Group/World Health Organization performance status grade of 0-4 and who test positive for the EGFR mutation prior to first-line thera­py should be treated with erlotinib, ac­cording to the NCCN guidelines. 

Alternatively, the guidelines state that gefitinib can be used in place of erlotinib “in areas of the world where it is avail­able.” 

For patients in whom the EGFR mu­tation is discovered during chemothera­py, the guidelines recommend either adding erlotinib to the current chemotherapy protocol or switching to erlotinib as maintenance treatment.

For patients whose EGFR status is negative or unknown, even in the pres­ence of clinical characteristics that might be suggestive of a mutation (for exam­ple, female, nonsmoker, Asian race), con­ventional chemotherapy is recommended, Dr. Ettinger said. 

In an editorial that accompanied ASCO’s PCO announcement, Dr. Paul A. Bunn Jr. and Dr. Robert C. Doebele of the University of Colorado Cancer Center in Aurora wrote that the grow­ing clinical importance of molecularly defined subgroups of adenocarcinoma signals a “new era of personalized med­icine for patients with advanced lung cancer, in which it will be imperative to match the specific mutations of a patient’s tumor with a specific therapy.” 

The implemen­tation of routine, simultaneous testing of multiple markers will likely be con­ducted on all patients prior to treat­ment initiation, regardless of clinical features, they stated, acknowledging certain procedural challenges, includ­ing obtaining adequate tumor materi­al at the time of diagnostic biopsy and developing testing platforms “that si­multaneously analyze for the presence of somatic mutations, gene fusions, or other genetic challenges.”

The updated NCCN Guidelines for NSCLC are posted at www.nccn.org. The ASCO PCO is posted at www.asco.org/ascov2/Practice+&+Guidelines/Guidelines/Provisional+Clinical+Opinion.

Dr. Ettinger has consultancy agree­ments with the a number of pharma­ceutical companies Dr. Keedy receives commercial research support from Ari­ad Pharmaceuticals, Ziopharm Oncolo­gy, and Amgen Oncology Therapeutics. Dr. Bunn has a consultant or advisory role with a number of pharmaceutical companies. Dr. Doebele disclosed re­search funding from Lilly, ImClone Sys­tems, and Pfizer.

Major Finding: The majority (76%) of parents report trusting their child's doctor “a lot,” with the next most likely sources to be trusted other health care providers (26%) and government experts (23%). Family and friends, as well as parents who believe vaccines harmed their children, were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, whereas celebrities were trusted a lot by 2% and somewhat by 24%.

Data Source: A national online study of 1,552 parents of children aged 17 years or younger.

Disclosures: Dr. Freed and his colleagues involved in the study of sources of vaccine safety information disclosed having no relevant financial disclosures. Dr. Nicola P. Klein of Stanford (Calif.) University, a coinvestigator in the study of the timing of immunization information to mothers, has received research support from GlaxoSmithKline, Merck, Sanofi Pasteur, Wyeth, Novartis, and MedImmune. Ms. Vannice was supported in part by a National Institutes of Health Training Grant in International Maternal and Child Health. None of the other investigators in that study said they had any relevant financial disclosures. The study was performed in collaboration between the CDC-funded Vaccine Attitudes and Risk Perception (VARP) and Clinical Immunization Safety Assessment (CISA) groups.

Most parents trust their children's doctor as the primary source for vaccine safety information, but those who feel physicians do not provide enough information may look to untraditional sources of safety information, including celebrities and parents who believe their own child was harmed by a vaccine, results of one study has shown.

As part of a larger study of parents and nonparents recruited for a national online panel, 1,552 of 2,521 (62%) parents of children aged 17 years or younger responded to a survey about trust of vaccine safety information sources, Dr. Gary L. Freed and his colleagues at the University of Michigan, Ann Arbor, reported in a supplement to the May issue of Pediatrics.

The survey asked parents if they place “a lot” of trust, “some” trust, or “no” trust in certain individuals or groups who provide vaccine safety information, including their children's doctor, other health care providers, government vaccine experts or officials, family and friends, parents who claim their child was harmed by a vaccine, and celebrities.

“The great majority [76%] of parents report trusting their child's doctor a lot,” the authors wrote, noting that the next most likely sources to be trusted were other health care providers (26%) and government experts (23%).

Family and friends, as well as parents who believe vaccines harmed their children, were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, whereas celebrities were trusted a lot by 2% and somewhat by 24%, Dr. Freed and his colleagues reported (Pediatrics 2011;127:S107-12).

Although approximately 27% of the respondents reported trusting Web sites from doctor groups, such as the American Academy of Pediatrics, “many parents reported that they do not use or view several potential sources of vaccine-safety information,” including government Web sites, magazines and news articles, television programs, pharmaceutical company Web sites, and the Web sites of antivaccine advocates, Dr. Freed and his associates said.

When the data were assessed by gender, there were significant differences.

“Mothers differed from fathers in that mothers were more likely to report some or a lot of trust in vaccine-safety information provided by parents who claim their child was injured by vaccines, celebrities, television shows, and magazines/news articles,” the investigators stated.

With respect to race/ethnicity, white and Hispanic parents were more likely than black parents were to place a lot or some trust in family and friends, while Hispanic parents were more likely than white or black parents were to trust celebrities a lot or some, they wrote.

“Other investigators have found that a significant number of parents feel that physicians do not provide enough information and that public health officials are not trustworthy,” Dr. Freed and his associates said. These parents' beliefs may be seen in the fact that they were more likely to trust celebrities or parents who claim their child was injured by vaccines. Usually, these sources use anecdotal information or personal accounts rather than population-based data or large clinical studies on which to base their perspectives.

The dissonance between health professionals and non–health professionals as trusted sources of vaccine safety information “is shaping the national dialogue on the issue,” the authors wrote, noting that the dissemination of information by untraditional sources is often not in the public's best interest. For example, the finding that 26% of the survey respondents trust celebrities as sources of vaccine safety information “is sobering,” Dr. Freed and his colleagues said.

“Celebrities are rarely trained in the ability to discern and critique the scientific literature, and they are not often expert in epidemiology, immunology, or toxicology.”

It is important that public health officials take note of the study findings when designing vaccine information media, they added.

“Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who are currently using other information sources. In particular, because the parents of many of today's infants are more facile with electronic means of communication and social networking websites, newer methods of promulgation should be explored.”

One promising communication strategy may be to target parents who have voiced concerns about vaccine safety with a comprehensive information packet and vaccine information statements before or even at the first vaccination visit, according to a study reported in the same issue of Pediatrics by Kirsten S. Vannice of the U.S. Department of Health and Human Services and her colleagues.

In that study, the investigators provided 272 mothers who had indicated concerns about vaccine safety with a new vaccine-information pamphlet and Vaccine Information Statements from the Centers for Disease Control and Prevention at one of three time points (prenatal visit, 1-week post partum well child visit, or 2-month vaccine visit), and used written surveys to assess their attitudes and beliefs about immunization before and after the review of materials. At all time points, distribution of the information “significantly improved attitudes about vaccination,” the authors wrote. “Allowing adequate time to review vaccine information at any visit may benefit concerned mothers,” they said (Pediatrics 2011;127:S120-6). However, the mothers indicated that they preferred receiving the information in advance of the 2-month vaccination visit.

Talk to Vaccine-Hesitant Parents

Inasmuch as the best defense is a good offense, the antidote to the plethora of vaccine safety misinformation from nonexpert sources is the targeted dissemination of accurate, evidence-based information to parents from their child's health care providers, vaccine experts suggested.

“[Health care providers] have the greatest influence on a parent's decision to vaccinate his or her child,” wrote Dr. C. Mary Healy and Dr. Larry K. Pickering (Pediatrics 2011;127:S127-33). For this reason, “establishing ongoing, nonconfrontational dialogue from the initial [physician]-parent interaction is essential when dealing with vaccine-hesitant parents,” said Dr. Healy of the Center for Vaccine Awareness and Research at Texas Children's Hospital, Houston, and Dr. Pickering of the CDC's National Center for Immunization and Respiratory Diseases

Toward this end, health care providers should take the following steps, the authors wrote:

▸ Make an effort to understand parental concerns about vaccination. “Although parental vaccine concerns vary according to knowledge and personal experience, the underlying premise remains remarkably consistent: fear that vaccines (and/or their additives) are unsafe, will give the immunized person the infection against which they are designed to protect, or that somehow getting the 'natural' disease is healthier.”

▸ Individualize each parent's set of concerns and avoid making assumptions about their attitudes.

▸ Establish an open, honest dialogue from the outset and provide Vaccine Information Statements as well as understandable summaries of research that address some of the common concerns, particularly those that have received media attention.

▸ Acknowledge the potential adverse events and balance them against disease risk.

▸ Provide personal anecdotes and visual imagery that highlight the dangers of refusing vaccination. “These stories are available in publications from reputable sources and online, where parent advocacy groups describe serious consequences of not vaccinating, or from organizations that specialize in vaccine education.”

▸ Ensure ongoing communication with parents, and deviate from the recommended childhood and adolescent immunization schedule only when other options have failed. Rather than discontinuing care for families who refuse or delay immunization, the physician “should reopen a nonconfrontational dialogue, continue to discuss risks and benefits of immunization during subsequent patient encounters, and document these discussions during each visit.”

“As physicians, we have a responsibility to provide guidance to parents,” Dr. Healy said in an interview, acknowledging the occasional difficulty of doing so when competing with other sources of information, including celebrities, non–health care providers, and very vocal antivaccine lobbies. “We have to be cognizant of the various factors that influence parents' perceptions about vaccine safety,” she said.

DR. HEALY disclosed she has a research grant from Sanofi Pasteur and has served on a scientific advisory board for Novartis Vaccines. DR. PICKERING disclosed having no relevant financial disclosures.

Major Finding: The majority (76%) of parents report trusting their child's doctor “a lot,” with the next most likely sources to be trusted other health care providers (26%) and government experts (23%). Family and friends, as well as parents who believe vaccines harmed their children, were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, whereas celebrities were trusted a lot by 2% and somewhat by 24%.

Data Source: A national online study of 1,552 parents of children aged 17 years or younger.

Disclosures: Dr. Freed and his colleagues involved in the study of sources of vaccine safety information disclosed having no relevant financial disclosures. Dr. Nicola P. Klein of Stanford (Calif.) University, a coinvestigator in the study of the timing of immunization information to mothers, has received research support from GlaxoSmithKline, Merck, Sanofi Pasteur, Wyeth, Novartis, and MedImmune. Ms. Vannice was supported in part by a National Institutes of Health Training Grant in International Maternal and Child Health. None of the other investigators in that study said they had any relevant financial disclosures. The study was performed in collaboration between the CDC-funded Vaccine Attitudes and Risk Perception (VARP) and Clinical Immunization Safety Assessment (CISA) groups.

Most parents trust their children's doctor as the primary source for vaccine safety information, but those who feel physicians do not provide enough information may look to untraditional sources of safety information, including celebrities and parents who believe their own child was harmed by a vaccine, results of one study has shown.

As part of a larger study of parents and nonparents recruited for a national online panel, 1,552 of 2,521 (62%) parents of children aged 17 years or younger responded to a survey about trust of vaccine safety information sources, Dr. Gary L. Freed and his colleagues at the University of Michigan, Ann Arbor, reported in a supplement to the May issue of Pediatrics.

The survey asked parents if they place “a lot” of trust, “some” trust, or “no” trust in certain individuals or groups who provide vaccine safety information, including their children's doctor, other health care providers, government vaccine experts or officials, family and friends, parents who claim their child was harmed by a vaccine, and celebrities.

“The great majority [76%] of parents report trusting their child's doctor a lot,” the authors wrote, noting that the next most likely sources to be trusted were other health care providers (26%) and government experts (23%).

Family and friends, as well as parents who believe vaccines harmed their children, were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, whereas celebrities were trusted a lot by 2% and somewhat by 24%, Dr. Freed and his colleagues reported (Pediatrics 2011;127:S107-12).

Although approximately 27% of the respondents reported trusting Web sites from doctor groups, such as the American Academy of Pediatrics, “many parents reported that they do not use or view several potential sources of vaccine-safety information,” including government Web sites, magazines and news articles, television programs, pharmaceutical company Web sites, and the Web sites of antivaccine advocates, Dr. Freed and his associates said.

When the data were assessed by gender, there were significant differences.

“Mothers differed from fathers in that mothers were more likely to report some or a lot of trust in vaccine-safety information provided by parents who claim their child was injured by vaccines, celebrities, television shows, and magazines/news articles,” the investigators stated.

With respect to race/ethnicity, white and Hispanic parents were more likely than black parents were to place a lot or some trust in family and friends, while Hispanic parents were more likely than white or black parents were to trust celebrities a lot or some, they wrote.

“Other investigators have found that a significant number of parents feel that physicians do not provide enough information and that public health officials are not trustworthy,” Dr. Freed and his associates said. These parents' beliefs may be seen in the fact that they were more likely to trust celebrities or parents who claim their child was injured by vaccines. Usually, these sources use anecdotal information or personal accounts rather than population-based data or large clinical studies on which to base their perspectives.

The dissonance between health professionals and non–health professionals as trusted sources of vaccine safety information “is shaping the national dialogue on the issue,” the authors wrote, noting that the dissemination of information by untraditional sources is often not in the public's best interest. For example, the finding that 26% of the survey respondents trust celebrities as sources of vaccine safety information “is sobering,” Dr. Freed and his colleagues said.

“Celebrities are rarely trained in the ability to discern and critique the scientific literature, and they are not often expert in epidemiology, immunology, or toxicology.”

It is important that public health officials take note of the study findings when designing vaccine information media, they added.

“Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who are currently using other information sources. In particular, because the parents of many of today's infants are more facile with electronic means of communication and social networking websites, newer methods of promulgation should be explored.”

One promising communication strategy may be to target parents who have voiced concerns about vaccine safety with a comprehensive information packet and vaccine information statements before or even at the first vaccination visit, according to a study reported in the same issue of Pediatrics by Kirsten S. Vannice of the U.S. Department of Health and Human Services and her colleagues.

In that study, the investigators provided 272 mothers who had indicated concerns about vaccine safety with a new vaccine-information pamphlet and Vaccine Information Statements from the Centers for Disease Control and Prevention at one of three time points (prenatal visit, 1-week post partum well child visit, or 2-month vaccine visit), and used written surveys to assess their attitudes and beliefs about immunization before and after the review of materials. At all time points, distribution of the information “significantly improved attitudes about vaccination,” the authors wrote. “Allowing adequate time to review vaccine information at any visit may benefit concerned mothers,” they said (Pediatrics 2011;127:S120-6). However, the mothers indicated that they preferred receiving the information in advance of the 2-month vaccination visit.

Talk to Vaccine-Hesitant Parents

Inasmuch as the best defense is a good offense, the antidote to the plethora of vaccine safety misinformation from nonexpert sources is the targeted dissemination of accurate, evidence-based information to parents from their child's health care providers, vaccine experts suggested.

“[Health care providers] have the greatest influence on a parent's decision to vaccinate his or her child,” wrote Dr. C. Mary Healy and Dr. Larry K. Pickering (Pediatrics 2011;127:S127-33). For this reason, “establishing ongoing, nonconfrontational dialogue from the initial [physician]-parent interaction is essential when dealing with vaccine-hesitant parents,” said Dr. Healy of the Center for Vaccine Awareness and Research at Texas Children's Hospital, Houston, and Dr. Pickering of the CDC's National Center for Immunization and Respiratory Diseases

Toward this end, health care providers should take the following steps, the authors wrote:

▸ Make an effort to understand parental concerns about vaccination. “Although parental vaccine concerns vary according to knowledge and personal experience, the underlying premise remains remarkably consistent: fear that vaccines (and/or their additives) are unsafe, will give the immunized person the infection against which they are designed to protect, or that somehow getting the 'natural' disease is healthier.”

▸ Individualize each parent's set of concerns and avoid making assumptions about their attitudes.

▸ Establish an open, honest dialogue from the outset and provide Vaccine Information Statements as well as understandable summaries of research that address some of the common concerns, particularly those that have received media attention.

▸ Acknowledge the potential adverse events and balance them against disease risk.

▸ Provide personal anecdotes and visual imagery that highlight the dangers of refusing vaccination. “These stories are available in publications from reputable sources and online, where parent advocacy groups describe serious consequences of not vaccinating, or from organizations that specialize in vaccine education.”

▸ Ensure ongoing communication with parents, and deviate from the recommended childhood and adolescent immunization schedule only when other options have failed. Rather than discontinuing care for families who refuse or delay immunization, the physician “should reopen a nonconfrontational dialogue, continue to discuss risks and benefits of immunization during subsequent patient encounters, and document these discussions during each visit.”

“As physicians, we have a responsibility to provide guidance to parents,” Dr. Healy said in an interview, acknowledging the occasional difficulty of doing so when competing with other sources of information, including celebrities, non–health care providers, and very vocal antivaccine lobbies. “We have to be cognizant of the various factors that influence parents' perceptions about vaccine safety,” she said.

DR. HEALY disclosed she has a research grant from Sanofi Pasteur and has served on a scientific advisory board for Novartis Vaccines. DR. PICKERING disclosed having no relevant financial disclosures.

Major Finding: The majority (76%) of parents report trusting their child's doctor “a lot,” with the next most likely sources to be trusted other health care providers (26%) and government experts (23%). Family and friends, as well as parents who believe vaccines harmed their children, were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, whereas celebrities were trusted a lot by 2% and somewhat by 24%.

Data Source: A national online study of 1,552 parents of children aged 17 years or younger.

Disclosures: Dr. Freed and his colleagues involved in the study of sources of vaccine safety information disclosed having no relevant financial disclosures. Dr. Nicola P. Klein of Stanford (Calif.) University, a coinvestigator in the study of the timing of immunization information to mothers, has received research support from GlaxoSmithKline, Merck, Sanofi Pasteur, Wyeth, Novartis, and MedImmune. Ms. Vannice was supported in part by a National Institutes of Health Training Grant in International Maternal and Child Health. None of the other investigators in that study said they had any relevant financial disclosures. The study was performed in collaboration between the CDC-funded Vaccine Attitudes and Risk Perception (VARP) and Clinical Immunization Safety Assessment (CISA) groups.

Most parents trust their children's doctor as the primary source for vaccine safety information, but those who feel physicians do not provide enough information may look to untraditional sources of safety information, including celebrities and parents who believe their own child was harmed by a vaccine, results of one study has shown.

As part of a larger study of parents and nonparents recruited for a national online panel, 1,552 of 2,521 (62%) parents of children aged 17 years or younger responded to a survey about trust of vaccine safety information sources, Dr. Gary L. Freed and his colleagues at the University of Michigan, Ann Arbor, reported in a supplement to the May issue of Pediatrics.

The survey asked parents if they place “a lot” of trust, “some” trust, or “no” trust in certain individuals or groups who provide vaccine safety information, including their children's doctor, other health care providers, government vaccine experts or officials, family and friends, parents who claim their child was harmed by a vaccine, and celebrities.

“The great majority [76%] of parents report trusting their child's doctor a lot,” the authors wrote, noting that the next most likely sources to be trusted were other health care providers (26%) and government experts (23%).

Family and friends, as well as parents who believe vaccines harmed their children, were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, whereas celebrities were trusted a lot by 2% and somewhat by 24%, Dr. Freed and his colleagues reported (Pediatrics 2011;127:S107-12).

Although approximately 27% of the respondents reported trusting Web sites from doctor groups, such as the American Academy of Pediatrics, “many parents reported that they do not use or view several potential sources of vaccine-safety information,” including government Web sites, magazines and news articles, television programs, pharmaceutical company Web sites, and the Web sites of antivaccine advocates, Dr. Freed and his associates said.

When the data were assessed by gender, there were significant differences.

“Mothers differed from fathers in that mothers were more likely to report some or a lot of trust in vaccine-safety information provided by parents who claim their child was injured by vaccines, celebrities, television shows, and magazines/news articles,” the investigators stated.

With respect to race/ethnicity, white and Hispanic parents were more likely than black parents were to place a lot or some trust in family and friends, while Hispanic parents were more likely than white or black parents were to trust celebrities a lot or some, they wrote.

“Other investigators have found that a significant number of parents feel that physicians do not provide enough information and that public health officials are not trustworthy,” Dr. Freed and his associates said. These parents' beliefs may be seen in the fact that they were more likely to trust celebrities or parents who claim their child was injured by vaccines. Usually, these sources use anecdotal information or personal accounts rather than population-based data or large clinical studies on which to base their perspectives.

The dissonance between health professionals and non–health professionals as trusted sources of vaccine safety information “is shaping the national dialogue on the issue,” the authors wrote, noting that the dissemination of information by untraditional sources is often not in the public's best interest. For example, the finding that 26% of the survey respondents trust celebrities as sources of vaccine safety information “is sobering,” Dr. Freed and his colleagues said.

“Celebrities are rarely trained in the ability to discern and critique the scientific literature, and they are not often expert in epidemiology, immunology, or toxicology.”

It is important that public health officials take note of the study findings when designing vaccine information media, they added.

“Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who are currently using other information sources. In particular, because the parents of many of today's infants are more facile with electronic means of communication and social networking websites, newer methods of promulgation should be explored.”

One promising communication strategy may be to target parents who have voiced concerns about vaccine safety with a comprehensive information packet and vaccine information statements before or even at the first vaccination visit, according to a study reported in the same issue of Pediatrics by Kirsten S. Vannice of the U.S. Department of Health and Human Services and her colleagues.

In that study, the investigators provided 272 mothers who had indicated concerns about vaccine safety with a new vaccine-information pamphlet and Vaccine Information Statements from the Centers for Disease Control and Prevention at one of three time points (prenatal visit, 1-week post partum well child visit, or 2-month vaccine visit), and used written surveys to assess their attitudes and beliefs about immunization before and after the review of materials. At all time points, distribution of the information “significantly improved attitudes about vaccination,” the authors wrote. “Allowing adequate time to review vaccine information at any visit may benefit concerned mothers,” they said (Pediatrics 2011;127:S120-6). However, the mothers indicated that they preferred receiving the information in advance of the 2-month vaccination visit.

Talk to Vaccine-Hesitant Parents

Inasmuch as the best defense is a good offense, the antidote to the plethora of vaccine safety misinformation from nonexpert sources is the targeted dissemination of accurate, evidence-based information to parents from their child's health care providers, vaccine experts suggested.

“[Health care providers] have the greatest influence on a parent's decision to vaccinate his or her child,” wrote Dr. C. Mary Healy and Dr. Larry K. Pickering (Pediatrics 2011;127:S127-33). For this reason, “establishing ongoing, nonconfrontational dialogue from the initial [physician]-parent interaction is essential when dealing with vaccine-hesitant parents,” said Dr. Healy of the Center for Vaccine Awareness and Research at Texas Children's Hospital, Houston, and Dr. Pickering of the CDC's National Center for Immunization and Respiratory Diseases

Toward this end, health care providers should take the following steps, the authors wrote:

▸ Make an effort to understand parental concerns about vaccination. “Although parental vaccine concerns vary according to knowledge and personal experience, the underlying premise remains remarkably consistent: fear that vaccines (and/or their additives) are unsafe, will give the immunized person the infection against which they are designed to protect, or that somehow getting the 'natural' disease is healthier.”

▸ Individualize each parent's set of concerns and avoid making assumptions about their attitudes.

▸ Establish an open, honest dialogue from the outset and provide Vaccine Information Statements as well as understandable summaries of research that address some of the common concerns, particularly those that have received media attention.

▸ Acknowledge the potential adverse events and balance them against disease risk.

▸ Provide personal anecdotes and visual imagery that highlight the dangers of refusing vaccination. “These stories are available in publications from reputable sources and online, where parent advocacy groups describe serious consequences of not vaccinating, or from organizations that specialize in vaccine education.”

▸ Ensure ongoing communication with parents, and deviate from the recommended childhood and adolescent immunization schedule only when other options have failed. Rather than discontinuing care for families who refuse or delay immunization, the physician “should reopen a nonconfrontational dialogue, continue to discuss risks and benefits of immunization during subsequent patient encounters, and document these discussions during each visit.”

“As physicians, we have a responsibility to provide guidance to parents,” Dr. Healy said in an interview, acknowledging the occasional difficulty of doing so when competing with other sources of information, including celebrities, non–health care providers, and very vocal antivaccine lobbies. “We have to be cognizant of the various factors that influence parents' perceptions about vaccine safety,” she said.

DR. HEALY disclosed she has a research grant from Sanofi Pasteur and has served on a scientific advisory board for Novartis Vaccines. DR. PICKERING disclosed having no relevant financial disclosures.

Systemic sclerosis and scleroderma are characterized by inflammation and fibrosis of the skin, as well as by vascular abnormalities, visceral damage, and the production of autoantibodies.

Diagnosing the chronic connective tissue disease, which can present in both limited and diffuse forms, can be complicated by the fact that it shares clinical and/or histologic features with a number of "scleroderma mimics," according to Dr. Janet E. Pope.

As with systemic sclerosis, most of these sclerodermalike conditions present with hard skin and tissue fibrosis and should be included in the differential diagnosis, noted Dr. Pope. She offered insight into ways to distinguish sclerodermalike fibrosing skin disorders from systemic sclerosis.

Skin & Allergy News: What are some of the more common "mimics" of systemic sclerosis.

Dr. Pope: Systemic sclerosis can be confused with such sclerodermalike skin disorders as eosinophilic fasciitis (EF), morphea, scleromyxedema, and nephrogenic systemic fibrosis (NSF).

SAN: How can physicians differentiate these from systemic sclerosis?

Dr. Pope: Most of these conditions lack Raynaud's phenomenon, sclerodactyly, and nailfold capillary changes.

Eosinophilic fasciitis (also called Shulman's syndrome) is a rare, localized, fibrosing disorder of subcutaneous tissues. Unlike systemic sclerosis, the overlying skin in EF is flexible enough to be pinched because the pathological disturbance is subcutaneous. This condition is often associated with venous grooving.

Generalized morphea is characterized by cutaneous sclerosis plaques caused by excessive collagen deposition, which leads to thickening of the dermis and/or subcutaneous tissues. Three or more major anatomical regions are affected by plaques in generalized morphea. Studies have shown that morphea often resolves within 2-5 years, but deeper lesions may take longer to resolve and may be accompanied by more disability and damage, depending on where they are located (J. Rheumatol. 1997;24:73-80). Additionally, many patients with morphea have antinuclear antibody and rheumatoid factor autoantibodies.

Scleromyxedema (also called papular mucinosis) is a chronic connective tissue disorder in which mucin deposits cause the skin to become red and raised, and make the movement of affected areas difficult. It tends to involve the head and neck rather than the extremities, and in most cases the sclerodermiform plaques and lichenoid papules are associated with a monoclonal gammopathy.

Finally, nephrogenic systemic fibrosis is a systemic fibrosing condition that occurs in people with kidney disease. NSF affects the skin, muscles, heart, and kidneys. It is strongly associated with exposure to gadolinium-based contrast agents.

Unlike systemic sclerosis, NSF tends to spare the skin of the face, and there is no association with autoantibodies or inflammatory cells.

The predominant histopathologic features of NSF include fibrocytelike cells, histiocytes, dermal dendritic cells, scarlike fibrosis, mucin, edema, calcification, and ossification. Diagnosing NSF requires both histopathologic and clinical findings.

SAN: Have any risk factors for the various conditions been identified?

Dr. Pope: As noted, NSF develops in patients with kidney disease and exposure to gadolinium. Renal failure is a major risk factor. With morphea, many patients who develop the condition are more likely than those without it to have an additional autoimmune disease.

SAN: How are the various conditions treated?

Dr. Pope: Corticosteroids and often methotrexate are used to treat EF, and early, aggressive treatment can minimize damage associated with the disease. Morphea is usually self-limited, and there is no proven treatment, although anecdotal evidence suggests that morphea patients who are being treated with antimalarials often develop new lesions when the treatment is stopped. IV immunoglobulin has been used in scleromyxedema treatment with mixed results.

Finally, there is no single therapeutic agent that has been proved effective for NSF. Anecdotal evidence suggests that extracorporeal photopheresis can lead to some lessening of skin thickening as well as increased mobility. Agents such as pentoxifylline, sodium, thiosulfate, and imatinib mesylate might improve skin fibrosis, but prevention through avoidance of gadolinium exposure in at-risk patients is advocated.

Dr. Pope is an associate professor of medicine in the division of rheumatology at the University of Western Ontario and a rheumatologist at St. Joseph's Health Care, both in London, Ont. She reported having no financial conflicts of interest.

Systemic sclerosis and scleroderma are characterized by inflammation and fibrosis of the skin, as well as by vascular abnormalities, visceral damage, and the production of autoantibodies.

Diagnosing the chronic connective tissue disease, which can present in both limited and diffuse forms, can be complicated by the fact that it shares clinical and/or histologic features with a number of "scleroderma mimics," according to Dr. Janet E. Pope.

As with systemic sclerosis, most of these sclerodermalike conditions present with hard skin and tissue fibrosis and should be included in the differential diagnosis, noted Dr. Pope. She offered insight into ways to distinguish sclerodermalike fibrosing skin disorders from systemic sclerosis.

Skin & Allergy News: What are some of the more common "mimics" of systemic sclerosis.

Dr. Pope: Systemic sclerosis can be confused with such sclerodermalike skin disorders as eosinophilic fasciitis (EF), morphea, scleromyxedema, and nephrogenic systemic fibrosis (NSF).

SAN: How can physicians differentiate these from systemic sclerosis?

Dr. Pope: Most of these conditions lack Raynaud's phenomenon, sclerodactyly, and nailfold capillary changes.

Eosinophilic fasciitis (also called Shulman's syndrome) is a rare, localized, fibrosing disorder of subcutaneous tissues. Unlike systemic sclerosis, the overlying skin in EF is flexible enough to be pinched because the pathological disturbance is subcutaneous. This condition is often associated with venous grooving.

Generalized morphea is characterized by cutaneous sclerosis plaques caused by excessive collagen deposition, which leads to thickening of the dermis and/or subcutaneous tissues. Three or more major anatomical regions are affected by plaques in generalized morphea. Studies have shown that morphea often resolves within 2-5 years, but deeper lesions may take longer to resolve and may be accompanied by more disability and damage, depending on where they are located (J. Rheumatol. 1997;24:73-80). Additionally, many patients with morphea have antinuclear antibody and rheumatoid factor autoantibodies.

Scleromyxedema (also called papular mucinosis) is a chronic connective tissue disorder in which mucin deposits cause the skin to become red and raised, and make the movement of affected areas difficult. It tends to involve the head and neck rather than the extremities, and in most cases the sclerodermiform plaques and lichenoid papules are associated with a monoclonal gammopathy.

Finally, nephrogenic systemic fibrosis is a systemic fibrosing condition that occurs in people with kidney disease. NSF affects the skin, muscles, heart, and kidneys. It is strongly associated with exposure to gadolinium-based contrast agents.

Unlike systemic sclerosis, NSF tends to spare the skin of the face, and there is no association with autoantibodies or inflammatory cells.

The predominant histopathologic features of NSF include fibrocytelike cells, histiocytes, dermal dendritic cells, scarlike fibrosis, mucin, edema, calcification, and ossification. Diagnosing NSF requires both histopathologic and clinical findings.

SAN: Have any risk factors for the various conditions been identified?

Dr. Pope: As noted, NSF develops in patients with kidney disease and exposure to gadolinium. Renal failure is a major risk factor. With morphea, many patients who develop the condition are more likely than those without it to have an additional autoimmune disease.

SAN: How are the various conditions treated?

Dr. Pope: Corticosteroids and often methotrexate are used to treat EF, and early, aggressive treatment can minimize damage associated with the disease. Morphea is usually self-limited, and there is no proven treatment, although anecdotal evidence suggests that morphea patients who are being treated with antimalarials often develop new lesions when the treatment is stopped. IV immunoglobulin has been used in scleromyxedema treatment with mixed results.

Finally, there is no single therapeutic agent that has been proved effective for NSF. Anecdotal evidence suggests that extracorporeal photopheresis can lead to some lessening of skin thickening as well as increased mobility. Agents such as pentoxifylline, sodium, thiosulfate, and imatinib mesylate might improve skin fibrosis, but prevention through avoidance of gadolinium exposure in at-risk patients is advocated.

Dr. Pope is an associate professor of medicine in the division of rheumatology at the University of Western Ontario and a rheumatologist at St. Joseph's Health Care, both in London, Ont. She reported having no financial conflicts of interest.

Systemic sclerosis and scleroderma are characterized by inflammation and fibrosis of the skin, as well as by vascular abnormalities, visceral damage, and the production of autoantibodies.

Diagnosing the chronic connective tissue disease, which can present in both limited and diffuse forms, can be complicated by the fact that it shares clinical and/or histologic features with a number of "scleroderma mimics," according to Dr. Janet E. Pope.

As with systemic sclerosis, most of these sclerodermalike conditions present with hard skin and tissue fibrosis and should be included in the differential diagnosis, noted Dr. Pope. She offered insight into ways to distinguish sclerodermalike fibrosing skin disorders from systemic sclerosis.

Skin & Allergy News: What are some of the more common "mimics" of systemic sclerosis.

Dr. Pope: Systemic sclerosis can be confused with such sclerodermalike skin disorders as eosinophilic fasciitis (EF), morphea, scleromyxedema, and nephrogenic systemic fibrosis (NSF).

SAN: How can physicians differentiate these from systemic sclerosis?

Dr. Pope: Most of these conditions lack Raynaud's phenomenon, sclerodactyly, and nailfold capillary changes.

Eosinophilic fasciitis (also called Shulman's syndrome) is a rare, localized, fibrosing disorder of subcutaneous tissues. Unlike systemic sclerosis, the overlying skin in EF is flexible enough to be pinched because the pathological disturbance is subcutaneous. This condition is often associated with venous grooving.

Generalized morphea is characterized by cutaneous sclerosis plaques caused by excessive collagen deposition, which leads to thickening of the dermis and/or subcutaneous tissues. Three or more major anatomical regions are affected by plaques in generalized morphea. Studies have shown that morphea often resolves within 2-5 years, but deeper lesions may take longer to resolve and may be accompanied by more disability and damage, depending on where they are located (J. Rheumatol. 1997;24:73-80). Additionally, many patients with morphea have antinuclear antibody and rheumatoid factor autoantibodies.

Scleromyxedema (also called papular mucinosis) is a chronic connective tissue disorder in which mucin deposits cause the skin to become red and raised, and make the movement of affected areas difficult. It tends to involve the head and neck rather than the extremities, and in most cases the sclerodermiform plaques and lichenoid papules are associated with a monoclonal gammopathy.

Finally, nephrogenic systemic fibrosis is a systemic fibrosing condition that occurs in people with kidney disease. NSF affects the skin, muscles, heart, and kidneys. It is strongly associated with exposure to gadolinium-based contrast agents.

Unlike systemic sclerosis, NSF tends to spare the skin of the face, and there is no association with autoantibodies or inflammatory cells.

The predominant histopathologic features of NSF include fibrocytelike cells, histiocytes, dermal dendritic cells, scarlike fibrosis, mucin, edema, calcification, and ossification. Diagnosing NSF requires both histopathologic and clinical findings.

SAN: Have any risk factors for the various conditions been identified?

Dr. Pope: As noted, NSF develops in patients with kidney disease and exposure to gadolinium. Renal failure is a major risk factor. With morphea, many patients who develop the condition are more likely than those without it to have an additional autoimmune disease.

SAN: How are the various conditions treated?

Dr. Pope: Corticosteroids and often methotrexate are used to treat EF, and early, aggressive treatment can minimize damage associated with the disease. Morphea is usually self-limited, and there is no proven treatment, although anecdotal evidence suggests that morphea patients who are being treated with antimalarials often develop new lesions when the treatment is stopped. IV immunoglobulin has been used in scleromyxedema treatment with mixed results.

Finally, there is no single therapeutic agent that has been proved effective for NSF. Anecdotal evidence suggests that extracorporeal photopheresis can lead to some lessening of skin thickening as well as increased mobility. Agents such as pentoxifylline, sodium, thiosulfate, and imatinib mesylate might improve skin fibrosis, but prevention through avoidance of gadolinium exposure in at-risk patients is advocated.

Dr. Pope is an associate professor of medicine in the division of rheumatology at the University of Western Ontario and a rheumatologist at St. Joseph's Health Care, both in London, Ont. She reported having no financial conflicts of interest.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

SAN ANTONIO – Single-incision laparoscopic cholecystectomy is as safe as the standard four-port laparoscopic procedure and delivers a more favorable cosmetic outcome for patients with gallstones, gallbladder polyps, and biliary dyskinesia, interim results of a continuing clinical trial have shown.

The trade-off for improved cosmesis, however, is increased postoperative pain, Dr. Melissa Phillips reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

In a prospective, randomized, controlled, single-blinded trial comparing single-incision laparoscopic cholecystectomy (SILC) with the four-port laparoscopic procedure (4PLC), Dr. Phillips of the University of Virginia Health Services in Charlottesville and her colleagues at University Hospitals Case Medical Center, Cleveland, compared operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy.

Also included in the analysis were rates of pain, patient satisfaction, and cosmetic scoring over 12 months of follow-up for 111 patients randomized to SILC and 85 patients randomized to 4PLC, all of whom were blinded for the first postoperative week.

Patients who were aged 18-85 years, were diagnosed with biliary colic, and had documented gallstones or polyps, or biliary dyskinesia with a documented ejection fraction that was less than 30%, were included in the study if they had a body mass index less than 45 kg/m², said Dr. Phillips. Exclusion criteria included pregnancy; calculus or acalculous cholecystitis; presence of an upper midline or right subcostal incision; preoperative indication for a cholangiogram; ASA (American Society of Anesthesiologists) score greater than 3; ongoing peritoneal dialysis; presence of umbilical hernia; or prior umbilical hernia or repair, she said.

SILC involves eversion of the umbilicus and a 20-mm fascial incision through which the flexible laparoscopic port is inserted into the peritoneal cavity, Dr. Phillips explained. For the multiport cholecystectomy, surgeons used 2- or 3-mm ports and one 10- or 12-mm port, with or without cholangiogram, she said. For both procedures, 5 mL of Marcaine was injected into the skin around each incision at the conclusion of the procedure followed by SteriStrip placement. Conversion to laparotomy or the placement of any additional ports was done at the surgeon’s discretion, she said.

BMI was significantly lower in the SILC group, compared with the 4PLC group (28.9 vs. 31.0), but all other patient characteristics were similar across both groups, Dr. Phillips said. One patient in the single-incision group required conversion to 4PLC because of intraoperative bleeding. There were no common bile duct injuries, but each arm had one port-site hernia and one episode of retained common duct stones, both of which were treated with ERCT (endoscopic retrograde cholangiopancreatography), she said.

Patients in the SILC group had a significantly longer median operative time than did the 4PLC patients (57 vs. 45 minutes) and significantly higher pain scores on a 10-point visual analog pain intensity scale on postoperative days 3 and 5, Dr. Phillips reported, although there was no difference in operative blood loss, analgesic use, or pain after day 5 between the two groups.

Cosmetic outcome was evaluated at 1 week, 2 weeks, 1 month, 3 months, and 1 year using the Body Image Questionnaire, Photo Series Questionnaire, and the modified Hollander Cosmesis Scale. "The self-reported body image and confidence scores, as well as the physician-reported Hollander scores, were similar in both groups except for month 1, when body image scores favored the single-incision group," Dr. Phillips said. At all time points, the patient-evaluated scar rating photo questionnaires significantly favored the SILC group, as did the cosmetic scale at weeks 1, 2, 4, and 12, she said.

Quality of life was assessed preoperatively and postoperatively on days 1, 3, and 5, and at 1 week via the short form–8 (SF-8) instrument; at 2 weeks and 1 month, SF-12 was used. "Satisfaction scores were statistically similar across almost all time points, but did significantly favor [4PLC] at 3 days for the SF-8 and at 4 weeks for the SF-12," Dr. Phillips reported. "This is likely related to the higher pain scores in the single-incision group at the early time points."

The findings are limited by the study’s small enrollment and inconsistent physician experience with both procedures, Dr. Phillips noted. "The complication rate associated with laparoscopic cholecystectomy is rare, so much larger numbers in both laparoscopic groups would be needed to evaluate the long-term safety" of SILC compared with that of standard laparoscopic cholecystectomy, she said. Additionally, although a minimum experience of 10 single-incision cases was required before enrollment at each site, she said, "it’s likely that many of the surgeons were still elevating on the learning curve."

Despite these limitations, the findings suggest that SILC is a safe – albeit initially more painful – alternative to the standard 4PLC. "The increased postoperative pain may be acceptable to patients who prefer a more cosmetic outcome," Dr. Phillips said.

Dr. Phillips disclosed a financial relationship with Covidien, sponsor of the study and maker of the single-incision port used in the investigation.

Most parents trust their children’s doctor as the primary source for vaccine safety information, but those who feel physicians do not provide enough information may look to untraditional sources of safety information, including celebrities and parents who believe their own child was harmed by a vaccine, results of one study has shown.

As part of a larger study of parents and nonparents recruited for a national online panel, 1,552 of 2,521 (62%) parents of children aged 17 years or younger responded to a survey about trust of vaccine safety information sources, Dr. Gary L. Freed and his colleagues at the University of Michigan, Ann Arbor, reported online today April 18 in a supplement to the May issue of Pediatrics.

The survey asked parents if they place "a lot" of trust, "some" trust, or "no" trust in certain individuals or groups who provide vaccine safety information, including their children’s doctor, other health care providers, government vaccine experts or officials, family and friends, parents who claim their child was harmed by a vaccine, and celebrities. "The great majority [76%] of parents report trusting their child’s doctor a lot," the authors wrote, noting that the next most likely sources to be trusted were other health care providers (26%) and government experts (23%). Family and friends, as well as parents who believe vaccines harmed their children were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, while celebrities were trusted a lot by 2% and somewhat by 24%, they reported (Pediatrics 2011;127:S107-12).

Although approximately 27% of the respondents reported trusting websites from doctor groups, such as the American Academy of Pediatrics, "many parents reported that they do not use or view several potential sources of vaccine-safety information," including government websites, magazines and news articles, television programs, drug company websites, and the websites of antivaccine advocates, Dr. Freed and his associates said.

When the data were assessed by gender, there were significant differences. "Mothers differed from fathers in that mothers were more likely to report some or a lot of trust in vaccine-safety information provided by parents who claim their child was injured by vaccines, celebrities, television shows, and magazines/news articles," they stated. With respect to race/ethnicity, white and Hispanic parents were more likely than black parents were to place a lot or some trust in family and friends, while Hispanic parents were more likely than white or black parents were to trust celebrities a lot or some, they wrote.

"Other investigators have found that a significant number of parents feel that physicians do not provide enough information and that public health officials are not trustworthy," Dr. Freed and his associates said. These parents’ beliefs may be seen in the fact that they were more likely to trust celebrities or parents who claim their child was injured by vaccines. Usually, these sources use anecdotal information or personal accounts rather than population-based data or large clinical studies on which to base their perspectives. The dissonance between health professionals and non–health professionals as trusted sources of vaccine safety information "is shaping the national dialogue on the issue," the authors wrote, noting that the dissemination of information by untraditional sources is often not in the public’s best interest. For example, the finding that 26% of the survey respondents trust celebrities as sources of vaccine safety information "is sobering," they said. "Celebrities are rarely trained in the ability to discern and critique the scientific literature, and they are not often expert in epidemiology, immunology, or toxicology."

Public health officials should take note of the study findings when designing vaccine information media, according to the Dr. Freed and his associates. "Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who are currently using other information sources. In particular, because the parents of many of today’s infants are more facile with electronic means of communication and social networking websites, newer methods of promulgation should be explored."

One promising communication strategy may be to target parents who have voiced concerns about vaccine safety with a comprehensive information packet and vaccine information statements before or even at the first vaccination visit, according to a study reported in the same issue of Pediatrics by Kirsten S. Vannice of the U.S. Department of Health and Human Services and her colleagues. The investigators provided 272 mothers who had indicated concerns about vaccine safety with a new vaccine-information pamphlet and Vaccine Information Statements from the Centers for Disease Control and Prevention at one of three time points (prenatal visit, 1-week post partum well child visit, or 2-month vaccine visit) and used written surveys to assess their attitudes and beliefs about immunization before and after the review of materials. At all time points, distribution of the information "significantly improved attitudes about vaccination," the authors wrote. "Allowing adequate time to review vaccine information at any visit may benefit concerned mothers" (Pediatrics 2011;127:S120-6). However, the mothers indicated that they preferred receiving the information before the 2-month vaccination visit.

Dr. Freed and his colleagues involved in the study of sources of vaccine safety information disclosed having no relevant financial disclosures. Dr. Nicola P. Klein of Stanford (Calif.) University, a coinvestigator in the study of the timing of immunization information to mothers, has received research support from GlaxoSmithKline, Merck & Co. Inc., Sanofi Pasteur, Wyeth, Novartis, and MedImmune. Ms. Vannice was supported in part by a National Institutes of Health Research and Training Grant in International Maternal and Child Health. None of the other investigators in that study said they had any relevant financial disclosures. The study was performed in collaboration between the CDC–funded Vaccine Attitudes and Risk Perception (VARP) and Clinical Immunization Safety Assessment (CISA) groups.

Most parents trust their children’s doctor as the primary source for vaccine safety information, but those who feel physicians do not provide enough information may look to untraditional sources of safety information, including celebrities and parents who believe their own child was harmed by a vaccine, results of one study has shown.

As part of a larger study of parents and nonparents recruited for a national online panel, 1,552 of 2,521 (62%) parents of children aged 17 years or younger responded to a survey about trust of vaccine safety information sources, Dr. Gary L. Freed and his colleagues at the University of Michigan, Ann Arbor, reported online today April 18 in a supplement to the May issue of Pediatrics.

The survey asked parents if they place "a lot" of trust, "some" trust, or "no" trust in certain individuals or groups who provide vaccine safety information, including their children’s doctor, other health care providers, government vaccine experts or officials, family and friends, parents who claim their child was harmed by a vaccine, and celebrities. "The great majority [76%] of parents report trusting their child’s doctor a lot," the authors wrote, noting that the next most likely sources to be trusted were other health care providers (26%) and government experts (23%). Family and friends, as well as parents who believe vaccines harmed their children were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, while celebrities were trusted a lot by 2% and somewhat by 24%, they reported (Pediatrics 2011;127:S107-12).

Although approximately 27% of the respondents reported trusting websites from doctor groups, such as the American Academy of Pediatrics, "many parents reported that they do not use or view several potential sources of vaccine-safety information," including government websites, magazines and news articles, television programs, drug company websites, and the websites of antivaccine advocates, Dr. Freed and his associates said.

When the data were assessed by gender, there were significant differences. "Mothers differed from fathers in that mothers were more likely to report some or a lot of trust in vaccine-safety information provided by parents who claim their child was injured by vaccines, celebrities, television shows, and magazines/news articles," they stated. With respect to race/ethnicity, white and Hispanic parents were more likely than black parents were to place a lot or some trust in family and friends, while Hispanic parents were more likely than white or black parents were to trust celebrities a lot or some, they wrote.

"Other investigators have found that a significant number of parents feel that physicians do not provide enough information and that public health officials are not trustworthy," Dr. Freed and his associates said. These parents’ beliefs may be seen in the fact that they were more likely to trust celebrities or parents who claim their child was injured by vaccines. Usually, these sources use anecdotal information or personal accounts rather than population-based data or large clinical studies on which to base their perspectives. The dissonance between health professionals and non–health professionals as trusted sources of vaccine safety information "is shaping the national dialogue on the issue," the authors wrote, noting that the dissemination of information by untraditional sources is often not in the public’s best interest. For example, the finding that 26% of the survey respondents trust celebrities as sources of vaccine safety information "is sobering," they said. "Celebrities are rarely trained in the ability to discern and critique the scientific literature, and they are not often expert in epidemiology, immunology, or toxicology."

Public health officials should take note of the study findings when designing vaccine information media, according to the Dr. Freed and his associates. "Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who are currently using other information sources. In particular, because the parents of many of today’s infants are more facile with electronic means of communication and social networking websites, newer methods of promulgation should be explored."

One promising communication strategy may be to target parents who have voiced concerns about vaccine safety with a comprehensive information packet and vaccine information statements before or even at the first vaccination visit, according to a study reported in the same issue of Pediatrics by Kirsten S. Vannice of the U.S. Department of Health and Human Services and her colleagues. The investigators provided 272 mothers who had indicated concerns about vaccine safety with a new vaccine-information pamphlet and Vaccine Information Statements from the Centers for Disease Control and Prevention at one of three time points (prenatal visit, 1-week post partum well child visit, or 2-month vaccine visit) and used written surveys to assess their attitudes and beliefs about immunization before and after the review of materials. At all time points, distribution of the information "significantly improved attitudes about vaccination," the authors wrote. "Allowing adequate time to review vaccine information at any visit may benefit concerned mothers" (Pediatrics 2011;127:S120-6). However, the mothers indicated that they preferred receiving the information before the 2-month vaccination visit.

Dr. Freed and his colleagues involved in the study of sources of vaccine safety information disclosed having no relevant financial disclosures. Dr. Nicola P. Klein of Stanford (Calif.) University, a coinvestigator in the study of the timing of immunization information to mothers, has received research support from GlaxoSmithKline, Merck & Co. Inc., Sanofi Pasteur, Wyeth, Novartis, and MedImmune. Ms. Vannice was supported in part by a National Institutes of Health Research and Training Grant in International Maternal and Child Health. None of the other investigators in that study said they had any relevant financial disclosures. The study was performed in collaboration between the CDC–funded Vaccine Attitudes and Risk Perception (VARP) and Clinical Immunization Safety Assessment (CISA) groups.

Most parents trust their children’s doctor as the primary source for vaccine safety information, but those who feel physicians do not provide enough information may look to untraditional sources of safety information, including celebrities and parents who believe their own child was harmed by a vaccine, results of one study has shown.

As part of a larger study of parents and nonparents recruited for a national online panel, 1,552 of 2,521 (62%) parents of children aged 17 years or younger responded to a survey about trust of vaccine safety information sources, Dr. Gary L. Freed and his colleagues at the University of Michigan, Ann Arbor, reported online today April 18 in a supplement to the May issue of Pediatrics.

The survey asked parents if they place "a lot" of trust, "some" trust, or "no" trust in certain individuals or groups who provide vaccine safety information, including their children’s doctor, other health care providers, government vaccine experts or officials, family and friends, parents who claim their child was harmed by a vaccine, and celebrities. "The great majority [76%] of parents report trusting their child’s doctor a lot," the authors wrote, noting that the next most likely sources to be trusted were other health care providers (26%) and government experts (23%). Family and friends, as well as parents who believe vaccines harmed their children were considered to be somewhat trustworthy sources by 67% and 65% of the respondents, respectively, while celebrities were trusted a lot by 2% and somewhat by 24%, they reported (Pediatrics 2011;127:S107-12).

Although approximately 27% of the respondents reported trusting websites from doctor groups, such as the American Academy of Pediatrics, "many parents reported that they do not use or view several potential sources of vaccine-safety information," including government websites, magazines and news articles, television programs, drug company websites, and the websites of antivaccine advocates, Dr. Freed and his associates said.

When the data were assessed by gender, there were significant differences. "Mothers differed from fathers in that mothers were more likely to report some or a lot of trust in vaccine-safety information provided by parents who claim their child was injured by vaccines, celebrities, television shows, and magazines/news articles," they stated. With respect to race/ethnicity, white and Hispanic parents were more likely than black parents were to place a lot or some trust in family and friends, while Hispanic parents were more likely than white or black parents were to trust celebrities a lot or some, they wrote.

"Other investigators have found that a significant number of parents feel that physicians do not provide enough information and that public health officials are not trustworthy," Dr. Freed and his associates said. These parents’ beliefs may be seen in the fact that they were more likely to trust celebrities or parents who claim their child was injured by vaccines. Usually, these sources use anecdotal information or personal accounts rather than population-based data or large clinical studies on which to base their perspectives. The dissonance between health professionals and non–health professionals as trusted sources of vaccine safety information "is shaping the national dialogue on the issue," the authors wrote, noting that the dissemination of information by untraditional sources is often not in the public’s best interest. For example, the finding that 26% of the survey respondents trust celebrities as sources of vaccine safety information "is sobering," they said. "Celebrities are rarely trained in the ability to discern and critique the scientific literature, and they are not often expert in epidemiology, immunology, or toxicology."

Public health officials should take note of the study findings when designing vaccine information media, according to the Dr. Freed and his associates. "Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who are currently using other information sources. In particular, because the parents of many of today’s infants are more facile with electronic means of communication and social networking websites, newer methods of promulgation should be explored."

One promising communication strategy may be to target parents who have voiced concerns about vaccine safety with a comprehensive information packet and vaccine information statements before or even at the first vaccination visit, according to a study reported in the same issue of Pediatrics by Kirsten S. Vannice of the U.S. Department of Health and Human Services and her colleagues. The investigators provided 272 mothers who had indicated concerns about vaccine safety with a new vaccine-information pamphlet and Vaccine Information Statements from the Centers for Disease Control and Prevention at one of three time points (prenatal visit, 1-week post partum well child visit, or 2-month vaccine visit) and used written surveys to assess their attitudes and beliefs about immunization before and after the review of materials. At all time points, distribution of the information "significantly improved attitudes about vaccination," the authors wrote. "Allowing adequate time to review vaccine information at any visit may benefit concerned mothers" (Pediatrics 2011;127:S120-6). However, the mothers indicated that they preferred receiving the information before the 2-month vaccination visit.

Dr. Freed and his colleagues involved in the study of sources of vaccine safety information disclosed having no relevant financial disclosures. Dr. Nicola P. Klein of Stanford (Calif.) University, a coinvestigator in the study of the timing of immunization information to mothers, has received research support from GlaxoSmithKline, Merck & Co. Inc., Sanofi Pasteur, Wyeth, Novartis, and MedImmune. Ms. Vannice was supported in part by a National Institutes of Health Research and Training Grant in International Maternal and Child Health. None of the other investigators in that study said they had any relevant financial disclosures. The study was performed in collaboration between the CDC–funded Vaccine Attitudes and Risk Perception (VARP) and Clinical Immunization Safety Assessment (CISA) groups.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Early data suggest that robotic-assisted technology may be the vehicle that helps drive pancreatic cancer surgery into the mainstream, thanks in large part to the improved dexterity and visualization capabilities the technology provides, according to Dr. A. James Moser.

After performing 50 robotic pancreaticoduodenectomies, he and his colleagues at the University of Pittsburgh Medical Center believe robotic hepatobiliary-pancreatic (HPB) surgery is a reasonable and feasible approach for management of pancreatic cancer, Dr. Moser said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

"The majority of patients [mean age 67 years] had had prior surgery, more than half had major medical comorbidities, and a quarter of them had multiple major comorbidities," said Dr. Moser. The first 34 patients underwent classic pancreaticoduodenectomy, and the rest had pylorus-preserving surgery, he said. The mean operative time was 576 minutes, and the median estimated blood loss was 400 mL.

"The rates of transfusion and conversion to open procedures were both acceptable at approximately 20%, and the lymph node harvest was a median of 18, which exceeds the standard of 12 established in most papers," he said. Additionally, "of 25 adenocarcinomas, 22 had clearly negative margins, giving us an R0 resection rate of 88%."

With respect to postoperative outcomes, he said, "half of the pancreatic fistulae were clinically insignificant grade A, while 12% were more significant. The rates of major and minor complications are essentially identical to open procedures, and the reoperation rate, all the way out to 90 days was only 3%."

The investigators also compared their robotic results with those of contemporaneous laparoscopic procedures, looking specifically at the outcomes of 76 minimally invasive distal pancreatectomies performed within the past 2½ years, said Dr. Moser. Although patients were equivalent in age, body mass index, and American Society of Anesthesiologists (ASA) scores, the investigators found that there was less risk of the need for blood transfusions and conversion to open surgery, and better lymph node harvest with the robotic approach vs. laparoscopy, whereas fistula and complication rates were the same in robotic vs. laparoscopic procedures.

Dr. Moser offered the following observations about four important keys to success:

• Safety. "There is a fallacy of learning curves," Dr. Moser stated. "In the 21st century, you don’t get one. You have to get beyond it before you even start."

• Teamwork. "The idea of collaboration between two experienced surgeons is often overlooked," he said. "The use of robotic surgery has enabled us to get beyond the idea of the surgeon/assistant paradigm to enable four-hand surgery to be done minimally invasively."

• Comparative effectiveness research. "It’s essential that the technical outcomes and approaches of the minimally invasive procedure mirror precisely what we do in open procedures, because relative efficacy has to be determined based on the outcomes of two operations that are exactly equivalent except for the minimally invasive approach," he said. "The procedures also have to be approached without case selection bias and using a widely applicable strategy. It should be the rule, not the exception, that we be able to apply this technology to all patients who come to us for primary surgical therapy." Toward this end, the investigators use a validated prediction model based on preoperative imaging to maximize the R0 resection rate (HPB [Oxford] 2009;11:606-11).

• Transparency. "Effectiveness in this domain requires a commitment to quality assurance and quality improvement, and it has to be transparent. [At UPMC] we have a vast volume of complex HPB surgery that has led to individual and institutional competence. We have a robotic selection committee, and all patients are signed up for the IRB registry. We have an outcomes program that tracks 34 variables in real time. We established early on the idea of a ‘drop dead’ time of 6 hours, after which, if the resection is not complete, we convert to an open procedure so patients will not be harmed by excessively long operating times. The idea is outcomes, outcomes, outcomes."

"We will either find a way to make pancreatic cancer surgery less fearsome to people or we will make one," Dr. Moser said, borrowing from the Latin proverb "I’ll either find a way or make one" commonly attributed to Hannibal.

"If you look at recent studies on national failure to operate on early-stage pancreatic cancer, approximately 71% of people who were clinically stage I with the disease never underwent an operation in the U.S. as of 2007, which shows that the operation is at least as fearsome as the disease," he observed (Ann. Surg. 2007;246:173-80). "Any method that can potentially reduce the morbidity of this operation is going to be beneficial in patients with early-stage disease, at least in the absence of more efficacious chemotherapeutic agents."

Dr. Moser disclosed receiving grant/research support from Genentech.

SAN ANTONIO – Laparoscopic liver resection is a safe and effective option for hepatocellular carcinoma in patients with cirrhosis, a study has shown.

Multiple meta-analyses, case-cohort matched series, and single-center series have shown that laparoscopic hepatic resection (LHR) significantly reduces operative blood loss, risk of postoperative complications, duration of hospital stay, days of narcotic use, and days until oral intake, Kanazawa Akishige, Ph.D., said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

However, cirrhotic patients with hepatocellular carcinoma (HCC) are at increased risk for complications such as perioperative hemorrhage and postoperative ascites; as a result, they may have longer hospital stays. To determine whether LHR is safe, effective, and feasible in these patients, Dr. Akishige and colleagues at Osaka City General Hospital in Japan identified 245 patients who underwent liver resection for HCC between February 2006 and August 2010.

The investigators then studied the 90 patients in the series who had complete liver cirrhosis and underwent a partial hepatectomy. Of the 90 patients, 62 underwent hepatectomy via laparotomy and 28 had LHR, Dr. Akishige said, noting that both approaches employed an ultrasonic surgical aspirator and soft coagulation. Preoperatively, the two groups had comparable liver reserve function, assessed via indocyanine green retention rate at 15 minutes (ICG R15).

The results showed no significant difference in procedure time between the two groups, however "there was significantly less blood loss during surgery in the laparoscopy group than in the laparotomy group," Dr. Akishige said, reporting that 16 patients in the open group and no patients in the minimally invasive group required transfusion of red cell concentrates.

Additionally, rates of postoperative mortality and morbidity were significantly higher in the laparotomy group. "Two patients in the open group died, and 29 [46.8%] experienced postoperative morbidity, whereas there was no mortality or morbidity in the laparoscopy group," he said.

The specific causes of morbidity in the patients who underwent the open procedure included ascites (9), biliary collection (9), surgical site infection (6), intraabdominal abscess (4), and respiratory complications (1), Dr. Akishige reported. Due in large part to the increased morbidity, the mean duration of hospital stay in the laparotomy group was 35 days, compared with 12 days in patients who underwent the laparoscopic procedure, he said.

Among the specific advantages of LHR that contributed to earlier recovery and shorter hospital stays in cirrhotic patients are the fact that the minimally invasive approach minimizes abdominal injury, improves diaphragmatic kinetics, preserves collateral venous drainage, and leads to less postoperative ascites, according to Dr. Akishige.

"Our results show that the procedure is safe and feasible for the treatment of [HCC] in patients with cirrhosis and is associated with good short-term outcomes," he said.

Dr. Akishige disclosed no relevant conflicts of interest.

SAN ANTONIO – Laparoscopic liver resection is a safe and effective option for hepatocellular carcinoma in patients with cirrhosis, a study has shown.

Multiple meta-analyses, case-cohort matched series, and single-center series have shown that laparoscopic hepatic resection (LHR) significantly reduces operative blood loss, risk of postoperative complications, duration of hospital stay, days of narcotic use, and days until oral intake, Kanazawa Akishige, Ph.D., said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

However, cirrhotic patients with hepatocellular carcinoma (HCC) are at increased risk for complications such as perioperative hemorrhage and postoperative ascites; as a result, they may have longer hospital stays. To determine whether LHR is safe, effective, and feasible in these patients, Dr. Akishige and colleagues at Osaka City General Hospital in Japan identified 245 patients who underwent liver resection for HCC between February 2006 and August 2010.

The investigators then studied the 90 patients in the series who had complete liver cirrhosis and underwent a partial hepatectomy. Of the 90 patients, 62 underwent hepatectomy via laparotomy and 28 had LHR, Dr. Akishige said, noting that both approaches employed an ultrasonic surgical aspirator and soft coagulation. Preoperatively, the two groups had comparable liver reserve function, assessed via indocyanine green retention rate at 15 minutes (ICG R15).

The results showed no significant difference in procedure time between the two groups, however "there was significantly less blood loss during surgery in the laparoscopy group than in the laparotomy group," Dr. Akishige said, reporting that 16 patients in the open group and no patients in the minimally invasive group required transfusion of red cell concentrates.

Additionally, rates of postoperative mortality and morbidity were significantly higher in the laparotomy group. "Two patients in the open group died, and 29 [46.8%] experienced postoperative morbidity, whereas there was no mortality or morbidity in the laparoscopy group," he said.

The specific causes of morbidity in the patients who underwent the open procedure included ascites (9), biliary collection (9), surgical site infection (6), intraabdominal abscess (4), and respiratory complications (1), Dr. Akishige reported. Due in large part to the increased morbidity, the mean duration of hospital stay in the laparotomy group was 35 days, compared with 12 days in patients who underwent the laparoscopic procedure, he said.

Among the specific advantages of LHR that contributed to earlier recovery and shorter hospital stays in cirrhotic patients are the fact that the minimally invasive approach minimizes abdominal injury, improves diaphragmatic kinetics, preserves collateral venous drainage, and leads to less postoperative ascites, according to Dr. Akishige.

"Our results show that the procedure is safe and feasible for the treatment of [HCC] in patients with cirrhosis and is associated with good short-term outcomes," he said.

Dr. Akishige disclosed no relevant conflicts of interest.

SAN ANTONIO – Laparoscopic liver resection is a safe and effective option for hepatocellular carcinoma in patients with cirrhosis, a study has shown.

Multiple meta-analyses, case-cohort matched series, and single-center series have shown that laparoscopic hepatic resection (LHR) significantly reduces operative blood loss, risk of postoperative complications, duration of hospital stay, days of narcotic use, and days until oral intake, Kanazawa Akishige, Ph.D., said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

However, cirrhotic patients with hepatocellular carcinoma (HCC) are at increased risk for complications such as perioperative hemorrhage and postoperative ascites; as a result, they may have longer hospital stays. To determine whether LHR is safe, effective, and feasible in these patients, Dr. Akishige and colleagues at Osaka City General Hospital in Japan identified 245 patients who underwent liver resection for HCC between February 2006 and August 2010.

The investigators then studied the 90 patients in the series who had complete liver cirrhosis and underwent a partial hepatectomy. Of the 90 patients, 62 underwent hepatectomy via laparotomy and 28 had LHR, Dr. Akishige said, noting that both approaches employed an ultrasonic surgical aspirator and soft coagulation. Preoperatively, the two groups had comparable liver reserve function, assessed via indocyanine green retention rate at 15 minutes (ICG R15).

The results showed no significant difference in procedure time between the two groups, however "there was significantly less blood loss during surgery in the laparoscopy group than in the laparotomy group," Dr. Akishige said, reporting that 16 patients in the open group and no patients in the minimally invasive group required transfusion of red cell concentrates.

Additionally, rates of postoperative mortality and morbidity were significantly higher in the laparotomy group. "Two patients in the open group died, and 29 [46.8%] experienced postoperative morbidity, whereas there was no mortality or morbidity in the laparoscopy group," he said.

The specific causes of morbidity in the patients who underwent the open procedure included ascites (9), biliary collection (9), surgical site infection (6), intraabdominal abscess (4), and respiratory complications (1), Dr. Akishige reported. Due in large part to the increased morbidity, the mean duration of hospital stay in the laparotomy group was 35 days, compared with 12 days in patients who underwent the laparoscopic procedure, he said.

Among the specific advantages of LHR that contributed to earlier recovery and shorter hospital stays in cirrhotic patients are the fact that the minimally invasive approach minimizes abdominal injury, improves diaphragmatic kinetics, preserves collateral venous drainage, and leads to less postoperative ascites, according to Dr. Akishige.

"Our results show that the procedure is safe and feasible for the treatment of [HCC] in patients with cirrhosis and is associated with good short-term outcomes," he said.

Dr. Akishige disclosed no relevant conflicts of interest.