Amy Karon

Certain endoscopic procedures carry the risk of tumor seeding. In prior studies, these rates were 0.005% to 0.009% for patients undergoing percutaneous abdominal biopsy, 1.6% for percutaneous radiofrequency ablation of hepatocellular carcinoma, and 2.7% for needle biopsy of hepatocellular carcinoma. When placing percutaneous endoscopic gastrostomy tubes, the “pull-through” technique is most common but “should be avoided in all patients with oropharyngeal or esophageal cancer,” the clinical practice update states. The authors cite multiple studies linking the pull-through technique to metastasis.

Clinicians also should avoid fine needle aspiration (FNA) of primary hilar cholangiocarcinomas, especially in patients who are surgical or transplant candidates, wrote Ferga C. Gleeson, MB, BCh, and her associates, MD Anderson Cancer Center, Houston. The report is in the September issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2018.05.014).

For patients with suspected pancreatic cancer, the clinical practice update recommends endoscopic ultrasound (EUS)–guided FNA “in any site within the gland when a confirmatory diagnosis of cancer would alter patient management.” The authors also emphasize promptly closing iatrogenic perforations during endoscopic mucosal resection and endoscopic submucosal dissection and practicing nonexposure techniques during endoscopic resection of subepithelial lesions.

For patients with cholangiocarcinoma, primary tumor FNA is controversial because it can be the sole means of cancer diagnosis but also significantly increases the risk of peritoneal metastasis, especially in the setting of larger tumor size, thicker needles, multiple passes, high-grade tumors, and scanty normal tissue along the needle tract, the experts note. Because FNA “may render a patient with cholangiocarcinoma ineligible for entry into a liver transplantation protocol,” it is “best to avoid” or at least discuss with a transplant hepatologist, they add.

However, EUS is appropriate when evaluating suspicious lymphadenopathy in liver transplantation candidates with cholangiocarcinoma, they note. This is because imaging techniques have inadequate sensitivity and a positive EUS result would preclude unnecessary neoadjuvant chemoradiation and staging laparotomy. If FNA is negative, patients do require staging laparotomy to verify the absence of nodal disease before transplantation, according to the clinical practice update.

Endoscopic mucosal and submucosal resection are valuable treatment options for esophageal, gastric, and colonic dysplasia and early carcinoma, but they also can lead to unintended gastrointestinal perforation. In past studies, rates of iatrogenic perforation were 1% when patients underwent endoscopic mucosal resection and 5% when they underwent submucosal resection. For patients with any stage of gastric cancer, an accidental perforation can seed the peritoneum with cancer cells from the contents of the stomach. Contact with a primary tumor also can cause shedding of tumor cells that can enter the peritoneal cavity through a perforation. Although most of these cases do not have clinically significant outcomes, perforations need to be promptly closed and should be avoided, if at all possible, during endoscopic full-thickness resections, the experts wrote.

They recommend using nonexposure techniques while resecting subepithelial tumors and call for more safety studies of endoscopic submucosal dissection of malignancies and endoscopic full-thickness resection of subepithelial lesions. “These studies should focus on individual reports or case series of peritoneal or mediastinal examination during surgery following failed resection of these lesions,” the authors concluded.

Dr. Gleeson and her associates disclosed no funding sources and reported having no conflicts of interest.

SOURCE: Gleeson FC et al. Clin Gastroenterol Hepatol. 2018 May 17. doi: 10.1016/j.cgh.2018.05.014.

Certain endoscopic procedures carry the risk of tumor seeding. In prior studies, these rates were 0.005% to 0.009% for patients undergoing percutaneous abdominal biopsy, 1.6% for percutaneous radiofrequency ablation of hepatocellular carcinoma, and 2.7% for needle biopsy of hepatocellular carcinoma. When placing percutaneous endoscopic gastrostomy tubes, the “pull-through” technique is most common but “should be avoided in all patients with oropharyngeal or esophageal cancer,” the clinical practice update states. The authors cite multiple studies linking the pull-through technique to metastasis.

Clinicians also should avoid fine needle aspiration (FNA) of primary hilar cholangiocarcinomas, especially in patients who are surgical or transplant candidates, wrote Ferga C. Gleeson, MB, BCh, and her associates, MD Anderson Cancer Center, Houston. The report is in the September issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2018.05.014).

For patients with suspected pancreatic cancer, the clinical practice update recommends endoscopic ultrasound (EUS)–guided FNA “in any site within the gland when a confirmatory diagnosis of cancer would alter patient management.” The authors also emphasize promptly closing iatrogenic perforations during endoscopic mucosal resection and endoscopic submucosal dissection and practicing nonexposure techniques during endoscopic resection of subepithelial lesions.

For patients with cholangiocarcinoma, primary tumor FNA is controversial because it can be the sole means of cancer diagnosis but also significantly increases the risk of peritoneal metastasis, especially in the setting of larger tumor size, thicker needles, multiple passes, high-grade tumors, and scanty normal tissue along the needle tract, the experts note. Because FNA “may render a patient with cholangiocarcinoma ineligible for entry into a liver transplantation protocol,” it is “best to avoid” or at least discuss with a transplant hepatologist, they add.

However, EUS is appropriate when evaluating suspicious lymphadenopathy in liver transplantation candidates with cholangiocarcinoma, they note. This is because imaging techniques have inadequate sensitivity and a positive EUS result would preclude unnecessary neoadjuvant chemoradiation and staging laparotomy. If FNA is negative, patients do require staging laparotomy to verify the absence of nodal disease before transplantation, according to the clinical practice update.

Endoscopic mucosal and submucosal resection are valuable treatment options for esophageal, gastric, and colonic dysplasia and early carcinoma, but they also can lead to unintended gastrointestinal perforation. In past studies, rates of iatrogenic perforation were 1% when patients underwent endoscopic mucosal resection and 5% when they underwent submucosal resection. For patients with any stage of gastric cancer, an accidental perforation can seed the peritoneum with cancer cells from the contents of the stomach. Contact with a primary tumor also can cause shedding of tumor cells that can enter the peritoneal cavity through a perforation. Although most of these cases do not have clinically significant outcomes, perforations need to be promptly closed and should be avoided, if at all possible, during endoscopic full-thickness resections, the experts wrote.

They recommend using nonexposure techniques while resecting subepithelial tumors and call for more safety studies of endoscopic submucosal dissection of malignancies and endoscopic full-thickness resection of subepithelial lesions. “These studies should focus on individual reports or case series of peritoneal or mediastinal examination during surgery following failed resection of these lesions,” the authors concluded.

Dr. Gleeson and her associates disclosed no funding sources and reported having no conflicts of interest.

SOURCE: Gleeson FC et al. Clin Gastroenterol Hepatol. 2018 May 17. doi: 10.1016/j.cgh.2018.05.014.

Certain endoscopic procedures carry the risk of tumor seeding. In prior studies, these rates were 0.005% to 0.009% for patients undergoing percutaneous abdominal biopsy, 1.6% for percutaneous radiofrequency ablation of hepatocellular carcinoma, and 2.7% for needle biopsy of hepatocellular carcinoma. When placing percutaneous endoscopic gastrostomy tubes, the “pull-through” technique is most common but “should be avoided in all patients with oropharyngeal or esophageal cancer,” the clinical practice update states. The authors cite multiple studies linking the pull-through technique to metastasis.

Clinicians also should avoid fine needle aspiration (FNA) of primary hilar cholangiocarcinomas, especially in patients who are surgical or transplant candidates, wrote Ferga C. Gleeson, MB, BCh, and her associates, MD Anderson Cancer Center, Houston. The report is in the September issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2018.05.014).

For patients with suspected pancreatic cancer, the clinical practice update recommends endoscopic ultrasound (EUS)–guided FNA “in any site within the gland when a confirmatory diagnosis of cancer would alter patient management.” The authors also emphasize promptly closing iatrogenic perforations during endoscopic mucosal resection and endoscopic submucosal dissection and practicing nonexposure techniques during endoscopic resection of subepithelial lesions.

For patients with cholangiocarcinoma, primary tumor FNA is controversial because it can be the sole means of cancer diagnosis but also significantly increases the risk of peritoneal metastasis, especially in the setting of larger tumor size, thicker needles, multiple passes, high-grade tumors, and scanty normal tissue along the needle tract, the experts note. Because FNA “may render a patient with cholangiocarcinoma ineligible for entry into a liver transplantation protocol,” it is “best to avoid” or at least discuss with a transplant hepatologist, they add.

However, EUS is appropriate when evaluating suspicious lymphadenopathy in liver transplantation candidates with cholangiocarcinoma, they note. This is because imaging techniques have inadequate sensitivity and a positive EUS result would preclude unnecessary neoadjuvant chemoradiation and staging laparotomy. If FNA is negative, patients do require staging laparotomy to verify the absence of nodal disease before transplantation, according to the clinical practice update.

Endoscopic mucosal and submucosal resection are valuable treatment options for esophageal, gastric, and colonic dysplasia and early carcinoma, but they also can lead to unintended gastrointestinal perforation. In past studies, rates of iatrogenic perforation were 1% when patients underwent endoscopic mucosal resection and 5% when they underwent submucosal resection. For patients with any stage of gastric cancer, an accidental perforation can seed the peritoneum with cancer cells from the contents of the stomach. Contact with a primary tumor also can cause shedding of tumor cells that can enter the peritoneal cavity through a perforation. Although most of these cases do not have clinically significant outcomes, perforations need to be promptly closed and should be avoided, if at all possible, during endoscopic full-thickness resections, the experts wrote.

They recommend using nonexposure techniques while resecting subepithelial tumors and call for more safety studies of endoscopic submucosal dissection of malignancies and endoscopic full-thickness resection of subepithelial lesions. “These studies should focus on individual reports or case series of peritoneal or mediastinal examination during surgery following failed resection of these lesions,” the authors concluded.

Dr. Gleeson and her associates disclosed no funding sources and reported having no conflicts of interest.

SOURCE: Gleeson FC et al. Clin Gastroenterol Hepatol. 2018 May 17. doi: 10.1016/j.cgh.2018.05.014.

Surveillance endoscopy should be spaced at 1 and 3 years after complete eradication of low-grade intestinal metaplasia and at 3 months, 6 months, 1 year, and then annually in cases of high-grade dysplasia, researchers wrote in Gastroenterology.

This “much-attenuated schedule of surveillance endoscopy would provide protection from invasive adenocarcinoma,” wrote Cary C. Cotton, MD, of the department of medicine at the University of North Carolina at Chapel Hill, with his associates. Following this schedule could prevent unnecessary endoscopies while still detecting unresectable cancers at rates under 1 in 1,000 endoscopies, they added.

Barrett’s esophagus recurs in at least one in four cases after successful radiofrequency ablation, the researchers noted. Therefore, surveillance endoscopy is recommended after complete eradication of intestinal metaplasia, but only expert opinion informs the frequency of surveillance. This study modeled and validated rates of neoplastic recurrence by using data from the United States Radiofrequency Ablation Registry during 2004-2013 and from the United Kingdom National Halo Registry during 2007-2015.

In line with prior research, predictors of neoplastic recurrence included baseline histologic grade, age, sex, endoscopic mucosal resection, and baseline length of Barrett’s esophagus, the researchers said. The strongest predictor of recurrence was the most severe histologic grade identified before complete eradication of intestinal metaplasia. After controlling for covariates, a model based only on most-severe baseline histology predicted neoplastic recurrence with a C statistic of 0.892 (95% confidence interval, 0.86-0.92) in the United States Radiofrequency Ablation Registry.

Dysplasia recurred at similar rates regardless of whether patients had nondysplastic Barrett’s esophagus or indeterminate dysplasia. Recurrence rates also were similar between patients with high-grade dysplasia and patients with intramucosal carcinoma. Thus, the researchers identified three risk groups based on most-severe baseline histology: dysplastic Barrett’s esophagus or indefinite for dysplasia, low-grade dysplasia, and high-grade lesions or intramucosal adenocarcinoma.

The annual rate of any-grade neoplastic recurrence was 0.19% in the lowest-risk group, 1.98% in the intermediate-risk group, and 5.93% in the highest-risk group. “In the higher-risk groups, neoplastic recurrence occurred at a higher rate in the first year, but at a constant estimated rate thereafter,” the investigators wrote. Among 114 initial cases of neoplastic recurrence, 1.8% were esophageal adenocarcinoma and another 1.8% of patients developed esophageal adenocarcinoma within 6 months.

The researchers then modeled surveillance intervals by assuming a 2.9% rate of neoplastic recurrence per visit, which yielded a 0.1% rate of invasive adenocarcinoma. “This level of risk tolerance was chosen so that the risk of complications from surveillance endoscopy – approximately one in 1,000 in this patient population – would roughly approximate the risk of invasive carcinoma discovered at the exam,” they wrote. For patients at higher risk of endoscopic complications, they set the rate of neoplastic recurrence at 5.7%, which yielded a 0.2% rate of invasive cancer. “As would be expected, the higher the risk tolerance, the longer the period between endoscopic surveillance intervals.”

Based on the model, the researchers proposed surveillance intervals of 1 year, followed by 3 years, followed by more than 5 years for patients with completely eradicated low-grade dysplasia. For cases of high-grade dysplasia or carcinoma in situ, the proposed surveillance intervals were 3 months, 6 months, 1 year, and then annually. The model also performed well when applied to data from the United Kingdom National Halo Registry, the investigators said, noting that their approach was the first to directly establish an evidence base for surveillance practices in Barrett’s esophagus.

SOURCE: Cotton CC et al. Gastroenterology. 2018 Apr 12. doi: 10.1053/j.gastro.2018.04.011.

Surveillance endoscopy should be spaced at 1 and 3 years after complete eradication of low-grade intestinal metaplasia and at 3 months, 6 months, 1 year, and then annually in cases of high-grade dysplasia, researchers wrote in Gastroenterology.

This “much-attenuated schedule of surveillance endoscopy would provide protection from invasive adenocarcinoma,” wrote Cary C. Cotton, MD, of the department of medicine at the University of North Carolina at Chapel Hill, with his associates. Following this schedule could prevent unnecessary endoscopies while still detecting unresectable cancers at rates under 1 in 1,000 endoscopies, they added.

Barrett’s esophagus recurs in at least one in four cases after successful radiofrequency ablation, the researchers noted. Therefore, surveillance endoscopy is recommended after complete eradication of intestinal metaplasia, but only expert opinion informs the frequency of surveillance. This study modeled and validated rates of neoplastic recurrence by using data from the United States Radiofrequency Ablation Registry during 2004-2013 and from the United Kingdom National Halo Registry during 2007-2015.

In line with prior research, predictors of neoplastic recurrence included baseline histologic grade, age, sex, endoscopic mucosal resection, and baseline length of Barrett’s esophagus, the researchers said. The strongest predictor of recurrence was the most severe histologic grade identified before complete eradication of intestinal metaplasia. After controlling for covariates, a model based only on most-severe baseline histology predicted neoplastic recurrence with a C statistic of 0.892 (95% confidence interval, 0.86-0.92) in the United States Radiofrequency Ablation Registry.

Dysplasia recurred at similar rates regardless of whether patients had nondysplastic Barrett’s esophagus or indeterminate dysplasia. Recurrence rates also were similar between patients with high-grade dysplasia and patients with intramucosal carcinoma. Thus, the researchers identified three risk groups based on most-severe baseline histology: dysplastic Barrett’s esophagus or indefinite for dysplasia, low-grade dysplasia, and high-grade lesions or intramucosal adenocarcinoma.

The annual rate of any-grade neoplastic recurrence was 0.19% in the lowest-risk group, 1.98% in the intermediate-risk group, and 5.93% in the highest-risk group. “In the higher-risk groups, neoplastic recurrence occurred at a higher rate in the first year, but at a constant estimated rate thereafter,” the investigators wrote. Among 114 initial cases of neoplastic recurrence, 1.8% were esophageal adenocarcinoma and another 1.8% of patients developed esophageal adenocarcinoma within 6 months.

The researchers then modeled surveillance intervals by assuming a 2.9% rate of neoplastic recurrence per visit, which yielded a 0.1% rate of invasive adenocarcinoma. “This level of risk tolerance was chosen so that the risk of complications from surveillance endoscopy – approximately one in 1,000 in this patient population – would roughly approximate the risk of invasive carcinoma discovered at the exam,” they wrote. For patients at higher risk of endoscopic complications, they set the rate of neoplastic recurrence at 5.7%, which yielded a 0.2% rate of invasive cancer. “As would be expected, the higher the risk tolerance, the longer the period between endoscopic surveillance intervals.”

Based on the model, the researchers proposed surveillance intervals of 1 year, followed by 3 years, followed by more than 5 years for patients with completely eradicated low-grade dysplasia. For cases of high-grade dysplasia or carcinoma in situ, the proposed surveillance intervals were 3 months, 6 months, 1 year, and then annually. The model also performed well when applied to data from the United Kingdom National Halo Registry, the investigators said, noting that their approach was the first to directly establish an evidence base for surveillance practices in Barrett’s esophagus.

SOURCE: Cotton CC et al. Gastroenterology. 2018 Apr 12. doi: 10.1053/j.gastro.2018.04.011.

Surveillance endoscopy should be spaced at 1 and 3 years after complete eradication of low-grade intestinal metaplasia and at 3 months, 6 months, 1 year, and then annually in cases of high-grade dysplasia, researchers wrote in Gastroenterology.

This “much-attenuated schedule of surveillance endoscopy would provide protection from invasive adenocarcinoma,” wrote Cary C. Cotton, MD, of the department of medicine at the University of North Carolina at Chapel Hill, with his associates. Following this schedule could prevent unnecessary endoscopies while still detecting unresectable cancers at rates under 1 in 1,000 endoscopies, they added.

Barrett’s esophagus recurs in at least one in four cases after successful radiofrequency ablation, the researchers noted. Therefore, surveillance endoscopy is recommended after complete eradication of intestinal metaplasia, but only expert opinion informs the frequency of surveillance. This study modeled and validated rates of neoplastic recurrence by using data from the United States Radiofrequency Ablation Registry during 2004-2013 and from the United Kingdom National Halo Registry during 2007-2015.

In line with prior research, predictors of neoplastic recurrence included baseline histologic grade, age, sex, endoscopic mucosal resection, and baseline length of Barrett’s esophagus, the researchers said. The strongest predictor of recurrence was the most severe histologic grade identified before complete eradication of intestinal metaplasia. After controlling for covariates, a model based only on most-severe baseline histology predicted neoplastic recurrence with a C statistic of 0.892 (95% confidence interval, 0.86-0.92) in the United States Radiofrequency Ablation Registry.

Dysplasia recurred at similar rates regardless of whether patients had nondysplastic Barrett’s esophagus or indeterminate dysplasia. Recurrence rates also were similar between patients with high-grade dysplasia and patients with intramucosal carcinoma. Thus, the researchers identified three risk groups based on most-severe baseline histology: dysplastic Barrett’s esophagus or indefinite for dysplasia, low-grade dysplasia, and high-grade lesions or intramucosal adenocarcinoma.

The annual rate of any-grade neoplastic recurrence was 0.19% in the lowest-risk group, 1.98% in the intermediate-risk group, and 5.93% in the highest-risk group. “In the higher-risk groups, neoplastic recurrence occurred at a higher rate in the first year, but at a constant estimated rate thereafter,” the investigators wrote. Among 114 initial cases of neoplastic recurrence, 1.8% were esophageal adenocarcinoma and another 1.8% of patients developed esophageal adenocarcinoma within 6 months.

The researchers then modeled surveillance intervals by assuming a 2.9% rate of neoplastic recurrence per visit, which yielded a 0.1% rate of invasive adenocarcinoma. “This level of risk tolerance was chosen so that the risk of complications from surveillance endoscopy – approximately one in 1,000 in this patient population – would roughly approximate the risk of invasive carcinoma discovered at the exam,” they wrote. For patients at higher risk of endoscopic complications, they set the rate of neoplastic recurrence at 5.7%, which yielded a 0.2% rate of invasive cancer. “As would be expected, the higher the risk tolerance, the longer the period between endoscopic surveillance intervals.”

Based on the model, the researchers proposed surveillance intervals of 1 year, followed by 3 years, followed by more than 5 years for patients with completely eradicated low-grade dysplasia. For cases of high-grade dysplasia or carcinoma in situ, the proposed surveillance intervals were 3 months, 6 months, 1 year, and then annually. The model also performed well when applied to data from the United Kingdom National Halo Registry, the investigators said, noting that their approach was the first to directly establish an evidence base for surveillance practices in Barrett’s esophagus.

SOURCE: Cotton CC et al. Gastroenterology. 2018 Apr 12. doi: 10.1053/j.gastro.2018.04.011.

Endoscopic screening was associated with an approximately 40% reduction in risk of death from gastric cancer in a systematic review and meta-analysis of studies from Asian countries.

The study is the first systematic review and meta-analysis of gastric cancer mortality and incidence after endoscopic screening, wrote Xing Zhang, MD, of the China Academy of Chinese Medical Sciences in Beijing with his associates. “Population-based prospective cohort studies are warranted to confirm our findings,” the reviewers wrote in the August issue of Gastroenterology.

In general, the rates of gastric cancer and related mortality in East Asian countries are significantly higher than global averages. As a result, countries in this region have implemented a variety of national and opportunistic screening programs that vary from country to country. Japan, for example, has a national screening program based on photofluorography. “Although data are inconsistent, most studies have shown a 40%-60% decrease in the mortality of gastric cancer in those who have been screened using photofluorography,” the reviewers noted. When findings are positive, follow-up endoscopy is recommended. However, debates persist about whether population-level endoscopy significantly improves hard endpoints in gastric cancer, such as incidence and mortality.

To help clarify the population-level benefits of endoscopic screening, Dr. Zhang and his associates searched PubMed and EMBASE; they identified six cohort studies and four nested case-control studies that included approximately 342,000 adults from Asia who did not have baseline gastric cancer but did undergo surveillance endoscopy at least once. Studies of both mass and opportunistic screening were included. Each study included a comparator; reported incidence, mortality, or both; and was published by March 8, 2018.

Endoscopic screening was tied to a 40% reduction in the relative risk of death from gastric cancer (risk ratio, 0.60; 95% confidence interval, 0.49-0.73). There also was a slight trend toward increased incidence of gastric cancer, which was not statistically significant (RR, 1.14; 95% CI, 0.93-1.40). However, only two studies examined the incidence of gastric cancer, so this outcome “should be interpreted with caution,” the reviewers wrote. Endoscopic screening also was associated with a significantly lower risk of death from gastric cancer, compared with radiographic screening (RR, 0.33; 95% CI, 0.12-0.91).

Endoscopic screening did not significantly reduce mortality, compared with expected deaths (RR, 0.67; 95% CI, 0.38-1.16), the reviewers reported. This might be because the reviewers included an outlier study conducted in Linqu County, China, which has some of the highest rates of gastric cancer death in the world, they noted. Endoscopic surveillance did not reduce mortality in the Linqu County study, but screenings were spaced by 4.5 years, which was probably too long to show an effect, especially in a high-risk region, they added. The study in Linqu County accounted for most of the heterogeneity among studies, and removing it from the pooled analysis produced a “slightly more pronounced reduction in gastric cancer mortality,” with an RR of 0.56, they noted.

Funders included the National Natural Science Foundation and the National Twelfth Five-Year Plan for Science and Technology Support Program of China. The reviewers reported having no relevant conflicts of interest.

SOURCE: Zhang X, et al. Gastroenterology. 2018 Apr 30. doi: 10.1053/j.gastro.2018.04.026.

Endoscopic screening was associated with an approximately 40% reduction in risk of death from gastric cancer in a systematic review and meta-analysis of studies from Asian countries.

The study is the first systematic review and meta-analysis of gastric cancer mortality and incidence after endoscopic screening, wrote Xing Zhang, MD, of the China Academy of Chinese Medical Sciences in Beijing with his associates. “Population-based prospective cohort studies are warranted to confirm our findings,” the reviewers wrote in the August issue of Gastroenterology.

In general, the rates of gastric cancer and related mortality in East Asian countries are significantly higher than global averages. As a result, countries in this region have implemented a variety of national and opportunistic screening programs that vary from country to country. Japan, for example, has a national screening program based on photofluorography. “Although data are inconsistent, most studies have shown a 40%-60% decrease in the mortality of gastric cancer in those who have been screened using photofluorography,” the reviewers noted. When findings are positive, follow-up endoscopy is recommended. However, debates persist about whether population-level endoscopy significantly improves hard endpoints in gastric cancer, such as incidence and mortality.

To help clarify the population-level benefits of endoscopic screening, Dr. Zhang and his associates searched PubMed and EMBASE; they identified six cohort studies and four nested case-control studies that included approximately 342,000 adults from Asia who did not have baseline gastric cancer but did undergo surveillance endoscopy at least once. Studies of both mass and opportunistic screening were included. Each study included a comparator; reported incidence, mortality, or both; and was published by March 8, 2018.

Endoscopic screening was tied to a 40% reduction in the relative risk of death from gastric cancer (risk ratio, 0.60; 95% confidence interval, 0.49-0.73). There also was a slight trend toward increased incidence of gastric cancer, which was not statistically significant (RR, 1.14; 95% CI, 0.93-1.40). However, only two studies examined the incidence of gastric cancer, so this outcome “should be interpreted with caution,” the reviewers wrote. Endoscopic screening also was associated with a significantly lower risk of death from gastric cancer, compared with radiographic screening (RR, 0.33; 95% CI, 0.12-0.91).

Endoscopic screening did not significantly reduce mortality, compared with expected deaths (RR, 0.67; 95% CI, 0.38-1.16), the reviewers reported. This might be because the reviewers included an outlier study conducted in Linqu County, China, which has some of the highest rates of gastric cancer death in the world, they noted. Endoscopic surveillance did not reduce mortality in the Linqu County study, but screenings were spaced by 4.5 years, which was probably too long to show an effect, especially in a high-risk region, they added. The study in Linqu County accounted for most of the heterogeneity among studies, and removing it from the pooled analysis produced a “slightly more pronounced reduction in gastric cancer mortality,” with an RR of 0.56, they noted.

Funders included the National Natural Science Foundation and the National Twelfth Five-Year Plan for Science and Technology Support Program of China. The reviewers reported having no relevant conflicts of interest.

SOURCE: Zhang X, et al. Gastroenterology. 2018 Apr 30. doi: 10.1053/j.gastro.2018.04.026.

Endoscopic screening was associated with an approximately 40% reduction in risk of death from gastric cancer in a systematic review and meta-analysis of studies from Asian countries.

The study is the first systematic review and meta-analysis of gastric cancer mortality and incidence after endoscopic screening, wrote Xing Zhang, MD, of the China Academy of Chinese Medical Sciences in Beijing with his associates. “Population-based prospective cohort studies are warranted to confirm our findings,” the reviewers wrote in the August issue of Gastroenterology.

In general, the rates of gastric cancer and related mortality in East Asian countries are significantly higher than global averages. As a result, countries in this region have implemented a variety of national and opportunistic screening programs that vary from country to country. Japan, for example, has a national screening program based on photofluorography. “Although data are inconsistent, most studies have shown a 40%-60% decrease in the mortality of gastric cancer in those who have been screened using photofluorography,” the reviewers noted. When findings are positive, follow-up endoscopy is recommended. However, debates persist about whether population-level endoscopy significantly improves hard endpoints in gastric cancer, such as incidence and mortality.

To help clarify the population-level benefits of endoscopic screening, Dr. Zhang and his associates searched PubMed and EMBASE; they identified six cohort studies and four nested case-control studies that included approximately 342,000 adults from Asia who did not have baseline gastric cancer but did undergo surveillance endoscopy at least once. Studies of both mass and opportunistic screening were included. Each study included a comparator; reported incidence, mortality, or both; and was published by March 8, 2018.

Endoscopic screening was tied to a 40% reduction in the relative risk of death from gastric cancer (risk ratio, 0.60; 95% confidence interval, 0.49-0.73). There also was a slight trend toward increased incidence of gastric cancer, which was not statistically significant (RR, 1.14; 95% CI, 0.93-1.40). However, only two studies examined the incidence of gastric cancer, so this outcome “should be interpreted with caution,” the reviewers wrote. Endoscopic screening also was associated with a significantly lower risk of death from gastric cancer, compared with radiographic screening (RR, 0.33; 95% CI, 0.12-0.91).

Endoscopic screening did not significantly reduce mortality, compared with expected deaths (RR, 0.67; 95% CI, 0.38-1.16), the reviewers reported. This might be because the reviewers included an outlier study conducted in Linqu County, China, which has some of the highest rates of gastric cancer death in the world, they noted. Endoscopic surveillance did not reduce mortality in the Linqu County study, but screenings were spaced by 4.5 years, which was probably too long to show an effect, especially in a high-risk region, they added. The study in Linqu County accounted for most of the heterogeneity among studies, and removing it from the pooled analysis produced a “slightly more pronounced reduction in gastric cancer mortality,” with an RR of 0.56, they noted.

Funders included the National Natural Science Foundation and the National Twelfth Five-Year Plan for Science and Technology Support Program of China. The reviewers reported having no relevant conflicts of interest.

SOURCE: Zhang X, et al. Gastroenterology. 2018 Apr 30. doi: 10.1053/j.gastro.2018.04.026.

With the help of gene expression signatures, a simulated treatment learning model identified which patients with multiple myeloma would benefit most from treatment with bortezomib or lenalidomide, researchers reported in Nature Communications.

The study included 910 participants across three phase 3 trials. In all, 20% would have a 100% greater-than-average progression-free survival (PFS) benefit from bortezomib, while 31% would have a 200% greater-than-average PFS benefit from lenalidomide, wrote Joske Ubels of University Center Utrecht, the Netherlands, and her colleagues.

The genetic heterogeneity of cancer and risk of treatment necessitate tools that “predict – at the moment of diagnosis – which patients will benefit most from a certain treatment,” the researchers wrote. While gene expression signatures can predict a favorable or adverse prognosis, they do not account for the effect of treatment on survival.

“The key idea of simulated treatment learning is that a patient’s treatment benefit can be estimated by comparing [his or her] survival to a set of genetically similar patients [who] received the comparator treatment,” they noted.

To do so, the researchers applied an algorithm called GESTURE to combined data from the TT2 (Total Therapy 2 for Multiple Myeloma), TT3, and HOVON-65/GMMG-HD4 trials. These trials compared bortezomib or lenalidomide with conventional therapies for multiple myeloma. The model identified 180 patients (20%) for whom bortezomib would produce a 100% greater PFS benefit than in the study population as a whole. Conversely, lenalidomide would produce a 200% greater PFS benefit in 31% of patients.

The simulated treatment learning model “can derive clinically actionable gene expression signatures that enable a more personalized approach to treatment,” the researchers concluded. The method requires a large dataset but could be useful for trials that have missed their primary endpoint, such as the CheckMate-026 trial of nivolumab. The next step is to see if the model makes useful treatment predictions for other cancers. The code needed to train and validate the model is available at github.com/jubels/GESTURE.

The Van Herk Fellowship provided support. The lenalidomide dataset was created as part of the Multiple Myeloma Research Foundation Personalized Medicine Initiative. Dr. Ubels and one coinvestigator are employees of SkylineDx; another coinvestigator served on its advisory board. The others reported having no relevant conflicts of interest.

SOURCE: Ubels J et al. Nat Commun. 2018 Jul 27. doi: 10.1038/s41467-018-05348-5.

With the help of gene expression signatures, a simulated treatment learning model identified which patients with multiple myeloma would benefit most from treatment with bortezomib or lenalidomide, researchers reported in Nature Communications.

The study included 910 participants across three phase 3 trials. In all, 20% would have a 100% greater-than-average progression-free survival (PFS) benefit from bortezomib, while 31% would have a 200% greater-than-average PFS benefit from lenalidomide, wrote Joske Ubels of University Center Utrecht, the Netherlands, and her colleagues.

The genetic heterogeneity of cancer and risk of treatment necessitate tools that “predict – at the moment of diagnosis – which patients will benefit most from a certain treatment,” the researchers wrote. While gene expression signatures can predict a favorable or adverse prognosis, they do not account for the effect of treatment on survival.

“The key idea of simulated treatment learning is that a patient’s treatment benefit can be estimated by comparing [his or her] survival to a set of genetically similar patients [who] received the comparator treatment,” they noted.

To do so, the researchers applied an algorithm called GESTURE to combined data from the TT2 (Total Therapy 2 for Multiple Myeloma), TT3, and HOVON-65/GMMG-HD4 trials. These trials compared bortezomib or lenalidomide with conventional therapies for multiple myeloma. The model identified 180 patients (20%) for whom bortezomib would produce a 100% greater PFS benefit than in the study population as a whole. Conversely, lenalidomide would produce a 200% greater PFS benefit in 31% of patients.

The simulated treatment learning model “can derive clinically actionable gene expression signatures that enable a more personalized approach to treatment,” the researchers concluded. The method requires a large dataset but could be useful for trials that have missed their primary endpoint, such as the CheckMate-026 trial of nivolumab. The next step is to see if the model makes useful treatment predictions for other cancers. The code needed to train and validate the model is available at github.com/jubels/GESTURE.

The Van Herk Fellowship provided support. The lenalidomide dataset was created as part of the Multiple Myeloma Research Foundation Personalized Medicine Initiative. Dr. Ubels and one coinvestigator are employees of SkylineDx; another coinvestigator served on its advisory board. The others reported having no relevant conflicts of interest.

SOURCE: Ubels J et al. Nat Commun. 2018 Jul 27. doi: 10.1038/s41467-018-05348-5.

With the help of gene expression signatures, a simulated treatment learning model identified which patients with multiple myeloma would benefit most from treatment with bortezomib or lenalidomide, researchers reported in Nature Communications.

The study included 910 participants across three phase 3 trials. In all, 20% would have a 100% greater-than-average progression-free survival (PFS) benefit from bortezomib, while 31% would have a 200% greater-than-average PFS benefit from lenalidomide, wrote Joske Ubels of University Center Utrecht, the Netherlands, and her colleagues.

The genetic heterogeneity of cancer and risk of treatment necessitate tools that “predict – at the moment of diagnosis – which patients will benefit most from a certain treatment,” the researchers wrote. While gene expression signatures can predict a favorable or adverse prognosis, they do not account for the effect of treatment on survival.

“The key idea of simulated treatment learning is that a patient’s treatment benefit can be estimated by comparing [his or her] survival to a set of genetically similar patients [who] received the comparator treatment,” they noted.

To do so, the researchers applied an algorithm called GESTURE to combined data from the TT2 (Total Therapy 2 for Multiple Myeloma), TT3, and HOVON-65/GMMG-HD4 trials. These trials compared bortezomib or lenalidomide with conventional therapies for multiple myeloma. The model identified 180 patients (20%) for whom bortezomib would produce a 100% greater PFS benefit than in the study population as a whole. Conversely, lenalidomide would produce a 200% greater PFS benefit in 31% of patients.

The simulated treatment learning model “can derive clinically actionable gene expression signatures that enable a more personalized approach to treatment,” the researchers concluded. The method requires a large dataset but could be useful for trials that have missed their primary endpoint, such as the CheckMate-026 trial of nivolumab. The next step is to see if the model makes useful treatment predictions for other cancers. The code needed to train and validate the model is available at github.com/jubels/GESTURE.

The Van Herk Fellowship provided support. The lenalidomide dataset was created as part of the Multiple Myeloma Research Foundation Personalized Medicine Initiative. Dr. Ubels and one coinvestigator are employees of SkylineDx; another coinvestigator served on its advisory board. The others reported having no relevant conflicts of interest.

SOURCE: Ubels J et al. Nat Commun. 2018 Jul 27. doi: 10.1038/s41467-018-05348-5.

For patients with pancreatic masses, infiltrated lymph nodes, or submucosal tumors, endoscopic ultrasound-guided fine-needle aspirate and fine-needle biopsy produced a comparable diagnostic yield with a similar number of needle passes, according to the results of a multicenter, randomized clinical trial.

Diagnostic yields were 91% for fine-needle aspirate versus 89% for fine-needle biopsy, with a median of one needle pass needed to obtain a diagnostic sample for each technique, reported Satish Nagula, MD, of the Icahn School of Medicine at Mount Sinai, New York, and his associates. The findings were published in the August issue of Clinical Gastroenterology and Hepatology.

Previously, two small, single-center randomized trials yielded conflicting data on whether fine-needle biopsy produces better diagnostic yield than fine-needle aspirate, the investigators noted. The results of four other studies indicated that the two techniques performed similarly. However, “many of these trials had study designs that did not allow for realistic comparisons of needle performance,” they noted. For example, the studies only analyzed the results of the first needle pass or only included specimens with visible core tissue.

The current study included six tertiary care centers that perform high volumes of endoscopic ultrasound. In all, 135 patients were randomly assigned to undergo fine-needle aspirate or fine-needle biopsy. When rapid on-site cytologic evaluation was used, the clinicians made consecutive needle passes until they considered the specimen adequate. Most lesions (77%) were masses, but 17% were lymph nodes, and 7% were submucosal tumors, the researchers said. The endoscopists used a curvilinear array echoendoscope (GF-UC140P or GF-UCT140; Olympus America, Central Valley, Penn.). They performed fine-needle aspirate or biopsy by using either a 22-gauge or 25-gauge needle at their own discretion.

The final diagnosis was malignancy for 70% of lesions, reactive lymphadenopathy for 11% of lesions, and spindle cell tumors in 9% of cases, the investigators said. Diagnostic yield was similar whether or not rapid on-site cytologic evaluation was used. Fine-needle aspiration detected cancer with a sensitivity of 90% and a specificity of 100%. Fine-needle biopsy had a sensitivity of 89% and a specificity of 100%. Adverse events were uncommon (1%), but one patient was hospitalized with pancreatitis for 2 days after undergoing fine-needle biopsy of a pancreatic body lesion.

The researchers noted several study limitations. “Ideally, each patient would undergo both fine-needle aspirate and fine-needle biopsy, allowing each as their own internal control,” they wrote. “It was considered too expensive to use two different needles in this unfunded study.” There also was no central pathology review, which they called “fiscally not feasible.”

There were no funding sources, and the investigators reported having no relevant conflicts of interest.SOURCE: Nagula S et al. Clin Gastroenterol Hepatol. 2017 Jun 14. doi: 10.1016/j.cgh.2017.06.013.

For patients with pancreatic masses, infiltrated lymph nodes, or submucosal tumors, endoscopic ultrasound-guided fine-needle aspirate and fine-needle biopsy produced a comparable diagnostic yield with a similar number of needle passes, according to the results of a multicenter, randomized clinical trial.

Diagnostic yields were 91% for fine-needle aspirate versus 89% for fine-needle biopsy, with a median of one needle pass needed to obtain a diagnostic sample for each technique, reported Satish Nagula, MD, of the Icahn School of Medicine at Mount Sinai, New York, and his associates. The findings were published in the August issue of Clinical Gastroenterology and Hepatology.

Previously, two small, single-center randomized trials yielded conflicting data on whether fine-needle biopsy produces better diagnostic yield than fine-needle aspirate, the investigators noted. The results of four other studies indicated that the two techniques performed similarly. However, “many of these trials had study designs that did not allow for realistic comparisons of needle performance,” they noted. For example, the studies only analyzed the results of the first needle pass or only included specimens with visible core tissue.

The current study included six tertiary care centers that perform high volumes of endoscopic ultrasound. In all, 135 patients were randomly assigned to undergo fine-needle aspirate or fine-needle biopsy. When rapid on-site cytologic evaluation was used, the clinicians made consecutive needle passes until they considered the specimen adequate. Most lesions (77%) were masses, but 17% were lymph nodes, and 7% were submucosal tumors, the researchers said. The endoscopists used a curvilinear array echoendoscope (GF-UC140P or GF-UCT140; Olympus America, Central Valley, Penn.). They performed fine-needle aspirate or biopsy by using either a 22-gauge or 25-gauge needle at their own discretion.

The final diagnosis was malignancy for 70% of lesions, reactive lymphadenopathy for 11% of lesions, and spindle cell tumors in 9% of cases, the investigators said. Diagnostic yield was similar whether or not rapid on-site cytologic evaluation was used. Fine-needle aspiration detected cancer with a sensitivity of 90% and a specificity of 100%. Fine-needle biopsy had a sensitivity of 89% and a specificity of 100%. Adverse events were uncommon (1%), but one patient was hospitalized with pancreatitis for 2 days after undergoing fine-needle biopsy of a pancreatic body lesion.

The researchers noted several study limitations. “Ideally, each patient would undergo both fine-needle aspirate and fine-needle biopsy, allowing each as their own internal control,” they wrote. “It was considered too expensive to use two different needles in this unfunded study.” There also was no central pathology review, which they called “fiscally not feasible.”

There were no funding sources, and the investigators reported having no relevant conflicts of interest.SOURCE: Nagula S et al. Clin Gastroenterol Hepatol. 2017 Jun 14. doi: 10.1016/j.cgh.2017.06.013.

For patients with pancreatic masses, infiltrated lymph nodes, or submucosal tumors, endoscopic ultrasound-guided fine-needle aspirate and fine-needle biopsy produced a comparable diagnostic yield with a similar number of needle passes, according to the results of a multicenter, randomized clinical trial.

Diagnostic yields were 91% for fine-needle aspirate versus 89% for fine-needle biopsy, with a median of one needle pass needed to obtain a diagnostic sample for each technique, reported Satish Nagula, MD, of the Icahn School of Medicine at Mount Sinai, New York, and his associates. The findings were published in the August issue of Clinical Gastroenterology and Hepatology.

Previously, two small, single-center randomized trials yielded conflicting data on whether fine-needle biopsy produces better diagnostic yield than fine-needle aspirate, the investigators noted. The results of four other studies indicated that the two techniques performed similarly. However, “many of these trials had study designs that did not allow for realistic comparisons of needle performance,” they noted. For example, the studies only analyzed the results of the first needle pass or only included specimens with visible core tissue.

The current study included six tertiary care centers that perform high volumes of endoscopic ultrasound. In all, 135 patients were randomly assigned to undergo fine-needle aspirate or fine-needle biopsy. When rapid on-site cytologic evaluation was used, the clinicians made consecutive needle passes until they considered the specimen adequate. Most lesions (77%) were masses, but 17% were lymph nodes, and 7% were submucosal tumors, the researchers said. The endoscopists used a curvilinear array echoendoscope (GF-UC140P or GF-UCT140; Olympus America, Central Valley, Penn.). They performed fine-needle aspirate or biopsy by using either a 22-gauge or 25-gauge needle at their own discretion.

The final diagnosis was malignancy for 70% of lesions, reactive lymphadenopathy for 11% of lesions, and spindle cell tumors in 9% of cases, the investigators said. Diagnostic yield was similar whether or not rapid on-site cytologic evaluation was used. Fine-needle aspiration detected cancer with a sensitivity of 90% and a specificity of 100%. Fine-needle biopsy had a sensitivity of 89% and a specificity of 100%. Adverse events were uncommon (1%), but one patient was hospitalized with pancreatitis for 2 days after undergoing fine-needle biopsy of a pancreatic body lesion.

The researchers noted several study limitations. “Ideally, each patient would undergo both fine-needle aspirate and fine-needle biopsy, allowing each as their own internal control,” they wrote. “It was considered too expensive to use two different needles in this unfunded study.” There also was no central pathology review, which they called “fiscally not feasible.”

There were no funding sources, and the investigators reported having no relevant conflicts of interest.SOURCE: Nagula S et al. Clin Gastroenterol Hepatol. 2017 Jun 14. doi: 10.1016/j.cgh.2017.06.013.

Among patients hospitalized with gastrointestinal and liver diseases, a clearly identifiable subset uses significantly more health care resources, which incurs significantly greater costs, according to the results of a national database analysis published in the August issue of Clinical Gastroenterology and Hepatology.

Compared with otherwise similar inpatients, these “high-need, high-cost” individuals are significantly more likely to be enrolled in Medicare or Medicaid, to have lower income, to initially be admitted to a large, rural hospital, to have multiple comorbidities, to be obese, or to be hospitalized for infection, said Nghia Nguyen, MD, and his associates. “[A] small fraction of high-need, high-cost patients contribute disproportionately to hospitalization costs,” they wrote. “Population health management directed toward these patients would facilitate high-value care.”

Gastrointestinal and liver diseases incur more than $100 billion in health care expenses annually in the United States, of which more than 60% is related to inpatient care, the researchers noted. However, few studies have comprehensively evaluated the annual burden and costs of hospitalization in patients with chronic gastrointestinal and liver diseases. Therefore, using the Nationwide Readmissions Database, the investigators studied patients with inflammatory bowel disease (IBD), chronic liver disease, functional gastrointestinal disorders, gastrointestinal hemorrhage, or pancreatic diseases who were hospitalized at least once during the first 6 months of 2013. All patients were diagnosed with IBD, chronic liver diseases, functional gastrointestinal disorders, gastrointestinal hemorrhage, or pancreatic diseases and followed for at least 6 months. The researchers stratified hospital days and costs and characterized the subset of patients who fell into the highest decile of days spent in the hospital per month.

The most common reason for hospitalization was chronic liver disease (nearly 377,000 patients), followed by functional gastrointestinal disorders (more than 351,000 patients), gastrointestinal hemorrhage (nearly 191,000 patients), pancreatic diseases (more than 98,000 patients), and IBD (more than 47,000 patients). Patients spent a median of 6-7 days in the hospital per year, with an interquartile range of 3-14 days. Compared with patients in the lowest decile for annual hospital stay (median, 0.13-0.14 days per month), patients in the highest decile spent a median of 3.7-5.1 days in the hospital per month. In this high-cost, high-need subset of patients, the costs of each hospitalization ranged from $7,438 per month to $11,425 per month, and they were typically hospitalized once every 2 months.

“Gastrointestinal diseases, infections, and cardiopulmonary causes were leading reasons for hospitalization of these patients,” the researchers wrote. “At a patient level, modifiable risk factors may include tackling the obesity epidemic and mental health issues and minimizing risk of iatrogenic or health care–associated infections, whereas at a health system level, interventions may include better access to care and connectivity between rural and specialty hospitals.”

Funders included the American College of Gastroenterology, the Crohn’s and Colitis Foundation, and the National Institutes of Health. Senior author Siddharth Singh disclosed unrelated grant funding from Pifzer and AbbVie. The other investigators reported having no conflicts of interest.

SOURCE: Nguyen NH et al. Clin Gastroenterol Hepatol. 2018 Feb 20. doi: 10.1016/j.cgh.2018.02.015.

Among patients hospitalized with gastrointestinal and liver diseases, a clearly identifiable subset uses significantly more health care resources, which incurs significantly greater costs, according to the results of a national database analysis published in the August issue of Clinical Gastroenterology and Hepatology.

Compared with otherwise similar inpatients, these “high-need, high-cost” individuals are significantly more likely to be enrolled in Medicare or Medicaid, to have lower income, to initially be admitted to a large, rural hospital, to have multiple comorbidities, to be obese, or to be hospitalized for infection, said Nghia Nguyen, MD, and his associates. “[A] small fraction of high-need, high-cost patients contribute disproportionately to hospitalization costs,” they wrote. “Population health management directed toward these patients would facilitate high-value care.”

Gastrointestinal and liver diseases incur more than $100 billion in health care expenses annually in the United States, of which more than 60% is related to inpatient care, the researchers noted. However, few studies have comprehensively evaluated the annual burden and costs of hospitalization in patients with chronic gastrointestinal and liver diseases. Therefore, using the Nationwide Readmissions Database, the investigators studied patients with inflammatory bowel disease (IBD), chronic liver disease, functional gastrointestinal disorders, gastrointestinal hemorrhage, or pancreatic diseases who were hospitalized at least once during the first 6 months of 2013. All patients were diagnosed with IBD, chronic liver diseases, functional gastrointestinal disorders, gastrointestinal hemorrhage, or pancreatic diseases and followed for at least 6 months. The researchers stratified hospital days and costs and characterized the subset of patients who fell into the highest decile of days spent in the hospital per month.

The most common reason for hospitalization was chronic liver disease (nearly 377,000 patients), followed by functional gastrointestinal disorders (more than 351,000 patients), gastrointestinal hemorrhage (nearly 191,000 patients), pancreatic diseases (more than 98,000 patients), and IBD (more than 47,000 patients). Patients spent a median of 6-7 days in the hospital per year, with an interquartile range of 3-14 days. Compared with patients in the lowest decile for annual hospital stay (median, 0.13-0.14 days per month), patients in the highest decile spent a median of 3.7-5.1 days in the hospital per month. In this high-cost, high-need subset of patients, the costs of each hospitalization ranged from $7,438 per month to $11,425 per month, and they were typically hospitalized once every 2 months.

“Gastrointestinal diseases, infections, and cardiopulmonary causes were leading reasons for hospitalization of these patients,” the researchers wrote. “At a patient level, modifiable risk factors may include tackling the obesity epidemic and mental health issues and minimizing risk of iatrogenic or health care–associated infections, whereas at a health system level, interventions may include better access to care and connectivity between rural and specialty hospitals.”

Funders included the American College of Gastroenterology, the Crohn’s and Colitis Foundation, and the National Institutes of Health. Senior author Siddharth Singh disclosed unrelated grant funding from Pifzer and AbbVie. The other investigators reported having no conflicts of interest.

SOURCE: Nguyen NH et al. Clin Gastroenterol Hepatol. 2018 Feb 20. doi: 10.1016/j.cgh.2018.02.015.

Among patients hospitalized with gastrointestinal and liver diseases, a clearly identifiable subset uses significantly more health care resources, which incurs significantly greater costs, according to the results of a national database analysis published in the August issue of Clinical Gastroenterology and Hepatology.

Compared with otherwise similar inpatients, these “high-need, high-cost” individuals are significantly more likely to be enrolled in Medicare or Medicaid, to have lower income, to initially be admitted to a large, rural hospital, to have multiple comorbidities, to be obese, or to be hospitalized for infection, said Nghia Nguyen, MD, and his associates. “[A] small fraction of high-need, high-cost patients contribute disproportionately to hospitalization costs,” they wrote. “Population health management directed toward these patients would facilitate high-value care.”

Gastrointestinal and liver diseases incur more than $100 billion in health care expenses annually in the United States, of which more than 60% is related to inpatient care, the researchers noted. However, few studies have comprehensively evaluated the annual burden and costs of hospitalization in patients with chronic gastrointestinal and liver diseases. Therefore, using the Nationwide Readmissions Database, the investigators studied patients with inflammatory bowel disease (IBD), chronic liver disease, functional gastrointestinal disorders, gastrointestinal hemorrhage, or pancreatic diseases who were hospitalized at least once during the first 6 months of 2013. All patients were diagnosed with IBD, chronic liver diseases, functional gastrointestinal disorders, gastrointestinal hemorrhage, or pancreatic diseases and followed for at least 6 months. The researchers stratified hospital days and costs and characterized the subset of patients who fell into the highest decile of days spent in the hospital per month.

The most common reason for hospitalization was chronic liver disease (nearly 377,000 patients), followed by functional gastrointestinal disorders (more than 351,000 patients), gastrointestinal hemorrhage (nearly 191,000 patients), pancreatic diseases (more than 98,000 patients), and IBD (more than 47,000 patients). Patients spent a median of 6-7 days in the hospital per year, with an interquartile range of 3-14 days. Compared with patients in the lowest decile for annual hospital stay (median, 0.13-0.14 days per month), patients in the highest decile spent a median of 3.7-5.1 days in the hospital per month. In this high-cost, high-need subset of patients, the costs of each hospitalization ranged from $7,438 per month to $11,425 per month, and they were typically hospitalized once every 2 months.

“Gastrointestinal diseases, infections, and cardiopulmonary causes were leading reasons for hospitalization of these patients,” the researchers wrote. “At a patient level, modifiable risk factors may include tackling the obesity epidemic and mental health issues and minimizing risk of iatrogenic or health care–associated infections, whereas at a health system level, interventions may include better access to care and connectivity between rural and specialty hospitals.”

Funders included the American College of Gastroenterology, the Crohn’s and Colitis Foundation, and the National Institutes of Health. Senior author Siddharth Singh disclosed unrelated grant funding from Pifzer and AbbVie. The other investigators reported having no conflicts of interest.

SOURCE: Nguyen NH et al. Clin Gastroenterol Hepatol. 2018 Feb 20. doi: 10.1016/j.cgh.2018.02.015.

Treatment with isavuconazole resolved or substantially improved invasive fungal disease among seven of eight patients receiving concomitant ibrutinib, according to the results of a small two-center study.

The combination “was well-tolerated overall,” wrote Kaelyn C. Cummins of Brigham and Women’s Hospital, together with her associates there and at the Dana-Farber Cancer Institute, Boston. Their letter to the editor was published in Leukemia & Lymphoma.

Although ibrutinib is considered less immunosuppressive than conventional chemotherapy, it has been tied to invasive fungal infections, even in seemingly low-risk patients. The preferred treatment, voriconazole, is a very strong inhibitor of cytochrome P450 systems, of which ibrutinib is a substrate. For this study, the researchers queried the pharmacy databases of their institutions to identify adults who received concomitant isavuconazole (200 mg per day) and ibrutinib between 2015 and 2018. Drug exposures were confirmed by medical record review.

Four patients experienced clinical and radiologic resolution of invasive aspergillosis, fusariosis, mucormycosis, or phaeohyphomycosis. Another three had clinical and radiologic improvement of confirmed or probable aspergillosis or histoplasmosis. One of these patients underwent five debridements for central nervous system invasive aspergillosis but had 8 months of clinical improvement between debridements. This patient’s fungal isolate remained susceptible to isavuconazole throughout treatment. The patient who did not respond at all to isavuconazole had invasive aspergillosis with recurrent brain abscesses. The fungal isolate remained susceptible to isavuconazole, and the patient switched to long-term voriconazole therapy after stopping ibrutinib.

Several adverse events occurred while patients were on concomitant therapy. One patient developed paroxysmal atrial fibrillation that persisted after stopping ibrutinib. Another had worsening of preexisting thrombocytopenia. Among four patients with electrocardiogram data, two had transient QTc prolongation. No patient died within 12 weeks of starting concomitant therapy. Two patients eventually died after their cancer progressed.

The median age of the patients was 60 years (range, 38-76 years). Five were men. Six had chronic lymphocytic leukemia (CLL) and two had marginal zone lymphoma. Two CLL patients were on ibrutinib monotherapy, two also received rituximab, one also received umbralisib, and one also received obinutuzumab. One patient with marginal zone lymphoma was on ibrutinib monotherapy, and the other received concomitant rituximab, gemcitabine, dexamethasone, and cisplatin.

Researchers should study the mechanisms by which [Bruton’s tyrosine kinase] inhibitors might increase susceptibility to fungal infections among patients with lymphoma or CLL, said Ms. Cummins and her associates. Because the CYP3A enzyme system also metabolizes PI3K and BCL-2 inhibitors, their results “could be more broadly applicable.”

Ms. Cummins had no disclosures.

SOURCE: Cummins KC et al. Leuk. Lymphoma 2018 Jul 24. doi: 10.1080/10428194.2018.1485913.

Treatment with isavuconazole resolved or substantially improved invasive fungal disease among seven of eight patients receiving concomitant ibrutinib, according to the results of a small two-center study.

The combination “was well-tolerated overall,” wrote Kaelyn C. Cummins of Brigham and Women’s Hospital, together with her associates there and at the Dana-Farber Cancer Institute, Boston. Their letter to the editor was published in Leukemia & Lymphoma.

Although ibrutinib is considered less immunosuppressive than conventional chemotherapy, it has been tied to invasive fungal infections, even in seemingly low-risk patients. The preferred treatment, voriconazole, is a very strong inhibitor of cytochrome P450 systems, of which ibrutinib is a substrate. For this study, the researchers queried the pharmacy databases of their institutions to identify adults who received concomitant isavuconazole (200 mg per day) and ibrutinib between 2015 and 2018. Drug exposures were confirmed by medical record review.

Four patients experienced clinical and radiologic resolution of invasive aspergillosis, fusariosis, mucormycosis, or phaeohyphomycosis. Another three had clinical and radiologic improvement of confirmed or probable aspergillosis or histoplasmosis. One of these patients underwent five debridements for central nervous system invasive aspergillosis but had 8 months of clinical improvement between debridements. This patient’s fungal isolate remained susceptible to isavuconazole throughout treatment. The patient who did not respond at all to isavuconazole had invasive aspergillosis with recurrent brain abscesses. The fungal isolate remained susceptible to isavuconazole, and the patient switched to long-term voriconazole therapy after stopping ibrutinib.

Several adverse events occurred while patients were on concomitant therapy. One patient developed paroxysmal atrial fibrillation that persisted after stopping ibrutinib. Another had worsening of preexisting thrombocytopenia. Among four patients with electrocardiogram data, two had transient QTc prolongation. No patient died within 12 weeks of starting concomitant therapy. Two patients eventually died after their cancer progressed.

The median age of the patients was 60 years (range, 38-76 years). Five were men. Six had chronic lymphocytic leukemia (CLL) and two had marginal zone lymphoma. Two CLL patients were on ibrutinib monotherapy, two also received rituximab, one also received umbralisib, and one also received obinutuzumab. One patient with marginal zone lymphoma was on ibrutinib monotherapy, and the other received concomitant rituximab, gemcitabine, dexamethasone, and cisplatin.

Researchers should study the mechanisms by which [Bruton’s tyrosine kinase] inhibitors might increase susceptibility to fungal infections among patients with lymphoma or CLL, said Ms. Cummins and her associates. Because the CYP3A enzyme system also metabolizes PI3K and BCL-2 inhibitors, their results “could be more broadly applicable.”

Ms. Cummins had no disclosures.

SOURCE: Cummins KC et al. Leuk. Lymphoma 2018 Jul 24. doi: 10.1080/10428194.2018.1485913.

Treatment with isavuconazole resolved or substantially improved invasive fungal disease among seven of eight patients receiving concomitant ibrutinib, according to the results of a small two-center study.

The combination “was well-tolerated overall,” wrote Kaelyn C. Cummins of Brigham and Women’s Hospital, together with her associates there and at the Dana-Farber Cancer Institute, Boston. Their letter to the editor was published in Leukemia & Lymphoma.

Although ibrutinib is considered less immunosuppressive than conventional chemotherapy, it has been tied to invasive fungal infections, even in seemingly low-risk patients. The preferred treatment, voriconazole, is a very strong inhibitor of cytochrome P450 systems, of which ibrutinib is a substrate. For this study, the researchers queried the pharmacy databases of their institutions to identify adults who received concomitant isavuconazole (200 mg per day) and ibrutinib between 2015 and 2018. Drug exposures were confirmed by medical record review.

Four patients experienced clinical and radiologic resolution of invasive aspergillosis, fusariosis, mucormycosis, or phaeohyphomycosis. Another three had clinical and radiologic improvement of confirmed or probable aspergillosis or histoplasmosis. One of these patients underwent five debridements for central nervous system invasive aspergillosis but had 8 months of clinical improvement between debridements. This patient’s fungal isolate remained susceptible to isavuconazole throughout treatment. The patient who did not respond at all to isavuconazole had invasive aspergillosis with recurrent brain abscesses. The fungal isolate remained susceptible to isavuconazole, and the patient switched to long-term voriconazole therapy after stopping ibrutinib.

Several adverse events occurred while patients were on concomitant therapy. One patient developed paroxysmal atrial fibrillation that persisted after stopping ibrutinib. Another had worsening of preexisting thrombocytopenia. Among four patients with electrocardiogram data, two had transient QTc prolongation. No patient died within 12 weeks of starting concomitant therapy. Two patients eventually died after their cancer progressed.

The median age of the patients was 60 years (range, 38-76 years). Five were men. Six had chronic lymphocytic leukemia (CLL) and two had marginal zone lymphoma. Two CLL patients were on ibrutinib monotherapy, two also received rituximab, one also received umbralisib, and one also received obinutuzumab. One patient with marginal zone lymphoma was on ibrutinib monotherapy, and the other received concomitant rituximab, gemcitabine, dexamethasone, and cisplatin.

Researchers should study the mechanisms by which [Bruton’s tyrosine kinase] inhibitors might increase susceptibility to fungal infections among patients with lymphoma or CLL, said Ms. Cummins and her associates. Because the CYP3A enzyme system also metabolizes PI3K and BCL-2 inhibitors, their results “could be more broadly applicable.”

Ms. Cummins had no disclosures.

SOURCE: Cummins KC et al. Leuk. Lymphoma 2018 Jul 24. doi: 10.1080/10428194.2018.1485913.

When patients lack typical symptoms of gastroesophageal reflux disease (GERD) and have extraesophageal symptoms, ENT, allergy, and pulmonary work-ups are “essential and often should be performed initially,” experts note in an American Gastroenterological Association clinical practice update.

Extraesophageal symptoms often are unrelated to GERD or are multifactorial, wrote Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and his associates in Clinical Gastroenterology and Hepatology. Gastroenterologists often are asked to look for reflux as the cause of extraesophageal symptoms before other etiologies have been ruled out.

Proposed extraesophageal manifestations of GERD range from chronic throat clearing and dysphonia to otitis, pulmonary fibrosis, laryngeal cancer, and even lung transplant rejection. Stronger evidence links GERD with symptoms of asthma, cough, and hoarseness, the experts note. “When less stringent criteria are used, the attributions are broader and could include sore throat, sinusitis, ear pain, and pulmonary fibrosis.”

When asked to assess whether GERD is causing extraesophageal symptoms, consider the “constellation” of patient presentation, test results, and treatment response, according to the clinical practice update. No diagnostic tests “unequivocally link any suspected extraesophageal symptom to GERD.” For patients who have both extraesophageal symptoms and typical symptoms of GERD, the authors suggest an evaluator regimen of 6-8 weeks of empiric, aggressive (twice-daily) proton pump inhibitor (PPI) therapy. If aggressive acid suppression therapy appears to improve extra­esophageal symptoms, patients should be titrated to the lowest effective treatment dose.If symptoms persist despite an aggressive trial of a PPI, and patients have a body mass index under 25, and a seemingly low probability of GERD, then the experts recommend pH testing “off” therapy and seeking other etiologies for extraesophageal symptoms. If symptoms persist and a patients’ BMI exceeds 25 with a high suspicion of GERD, they recommend evaluations for concomitant asthma or lung disease. If these work-ups are positive, they recommend multichannel intraluminal impedance testing or pH monitoring on treatment.

The clinical practice update strongly discourages surgical treatment of extraesophageal GERD symptoms except in specific populations, such as when patients have objective signs of treatment-refractory GERD and have not responded to comprehensive therapy for other possible causes of extraesophageal symptoms. Recent data suggest that surgery can benefit patients with confirmed structural defects, such as hiatal hernia, which are causing symptomatic, volume-based regurgitation, the experts note. Ideally, these patients should first undergo pH and impedance monitoring to objectively measure the effects of reflux. Additionally, surgical fundoplication “might be beneficial” for patients whose extraesophageal symptoms clearly have responded to PPI therapy but who refuse long-term PPI therapy or who develop unacceptable side effects.

The practice update also extensively discusses the role of testing to evaluate the role of GERD in extraesophageal symptoms. Barium esophagography is insensitive for GERD and is useful only for evaluating dysphagia and the size and type of a hiatal hernia, the experts note. Abnormal laryngoscopy or pharyngoscopic findings are more useful but should not be the “initial driving force” behind a GERD diagnosis and do not necessarily link GERD to extraesophageal symptoms. Likewise, esophagogastroduodenoscopy can identify esophagitis, which signifies GERD but does not establish it as etiologic.

Positive ambulatory pH or impedance monitoring or pharyngeal pH tests also do not definitively link reflux to suspected extraesophageal symptoms, the experts note. They suggest considering “on” therapy monitoring to evaluate treatment efficacy and to time reflux events relative to symptoms in patients with esophagitis, Barrett’s esophagus, or a large hiatal hernia. Conversely, they recommend considering “off” treatment testing to rule out GERD in patients who have no history of confirmed or suspected reflux and who have not responded to PPI therapy.

Novel tests, such as salivary pepsin and mucosal impedance, have “no clear role in establishing GERD as the cause of extraesophageal symptoms,” the experts emphasize. Clinician scientists also debate the exact pathophysiology of extraesophageal GERD sequelae. While chronic exposure to gastric refluxate clearly can harm proximal structures such as the pharynx, larynx, and bronchial tree, it remains unclear how much acid is necessary to cause injury and whether bile, pepsin, or neurogenic stimulation play a role.

Dr. Vaezi reported having no conflicts of interest. Senior author Frank Zerbib, MD, PhD, reported receiving devices for research purposes from Medtronic and Sandhill Scientific.
 

SOURCE: Vaezi MF et al. Clin Gastroenterol Hepatol. 2018 Feb 7. doi: 10.1016/j.cgh.2018.02.001.

When patients lack typical symptoms of gastroesophageal reflux disease (GERD) and have extraesophageal symptoms, ENT, allergy, and pulmonary work-ups are “essential and often should be performed initially,” experts note in an American Gastroenterological Association clinical practice update.

Extraesophageal symptoms often are unrelated to GERD or are multifactorial, wrote Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and his associates in Clinical Gastroenterology and Hepatology. Gastroenterologists often are asked to look for reflux as the cause of extraesophageal symptoms before other etiologies have been ruled out.

Proposed extraesophageal manifestations of GERD range from chronic throat clearing and dysphonia to otitis, pulmonary fibrosis, laryngeal cancer, and even lung transplant rejection. Stronger evidence links GERD with symptoms of asthma, cough, and hoarseness, the experts note. “When less stringent criteria are used, the attributions are broader and could include sore throat, sinusitis, ear pain, and pulmonary fibrosis.”

When asked to assess whether GERD is causing extraesophageal symptoms, consider the “constellation” of patient presentation, test results, and treatment response, according to the clinical practice update. No diagnostic tests “unequivocally link any suspected extraesophageal symptom to GERD.” For patients who have both extraesophageal symptoms and typical symptoms of GERD, the authors suggest an evaluator regimen of 6-8 weeks of empiric, aggressive (twice-daily) proton pump inhibitor (PPI) therapy. If aggressive acid suppression therapy appears to improve extra­esophageal symptoms, patients should be titrated to the lowest effective treatment dose.If symptoms persist despite an aggressive trial of a PPI, and patients have a body mass index under 25, and a seemingly low probability of GERD, then the experts recommend pH testing “off” therapy and seeking other etiologies for extraesophageal symptoms. If symptoms persist and a patients’ BMI exceeds 25 with a high suspicion of GERD, they recommend evaluations for concomitant asthma or lung disease. If these work-ups are positive, they recommend multichannel intraluminal impedance testing or pH monitoring on treatment.

The clinical practice update strongly discourages surgical treatment of extraesophageal GERD symptoms except in specific populations, such as when patients have objective signs of treatment-refractory GERD and have not responded to comprehensive therapy for other possible causes of extraesophageal symptoms. Recent data suggest that surgery can benefit patients with confirmed structural defects, such as hiatal hernia, which are causing symptomatic, volume-based regurgitation, the experts note. Ideally, these patients should first undergo pH and impedance monitoring to objectively measure the effects of reflux. Additionally, surgical fundoplication “might be beneficial” for patients whose extraesophageal symptoms clearly have responded to PPI therapy but who refuse long-term PPI therapy or who develop unacceptable side effects.

The practice update also extensively discusses the role of testing to evaluate the role of GERD in extraesophageal symptoms. Barium esophagography is insensitive for GERD and is useful only for evaluating dysphagia and the size and type of a hiatal hernia, the experts note. Abnormal laryngoscopy or pharyngoscopic findings are more useful but should not be the “initial driving force” behind a GERD diagnosis and do not necessarily link GERD to extraesophageal symptoms. Likewise, esophagogastroduodenoscopy can identify esophagitis, which signifies GERD but does not establish it as etiologic.

Positive ambulatory pH or impedance monitoring or pharyngeal pH tests also do not definitively link reflux to suspected extraesophageal symptoms, the experts note. They suggest considering “on” therapy monitoring to evaluate treatment efficacy and to time reflux events relative to symptoms in patients with esophagitis, Barrett’s esophagus, or a large hiatal hernia. Conversely, they recommend considering “off” treatment testing to rule out GERD in patients who have no history of confirmed or suspected reflux and who have not responded to PPI therapy.

Novel tests, such as salivary pepsin and mucosal impedance, have “no clear role in establishing GERD as the cause of extraesophageal symptoms,” the experts emphasize. Clinician scientists also debate the exact pathophysiology of extraesophageal GERD sequelae. While chronic exposure to gastric refluxate clearly can harm proximal structures such as the pharynx, larynx, and bronchial tree, it remains unclear how much acid is necessary to cause injury and whether bile, pepsin, or neurogenic stimulation play a role.

Dr. Vaezi reported having no conflicts of interest. Senior author Frank Zerbib, MD, PhD, reported receiving devices for research purposes from Medtronic and Sandhill Scientific.
 

SOURCE: Vaezi MF et al. Clin Gastroenterol Hepatol. 2018 Feb 7. doi: 10.1016/j.cgh.2018.02.001.

When patients lack typical symptoms of gastroesophageal reflux disease (GERD) and have extraesophageal symptoms, ENT, allergy, and pulmonary work-ups are “essential and often should be performed initially,” experts note in an American Gastroenterological Association clinical practice update.

Extraesophageal symptoms often are unrelated to GERD or are multifactorial, wrote Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and his associates in Clinical Gastroenterology and Hepatology. Gastroenterologists often are asked to look for reflux as the cause of extraesophageal symptoms before other etiologies have been ruled out.

Proposed extraesophageal manifestations of GERD range from chronic throat clearing and dysphonia to otitis, pulmonary fibrosis, laryngeal cancer, and even lung transplant rejection. Stronger evidence links GERD with symptoms of asthma, cough, and hoarseness, the experts note. “When less stringent criteria are used, the attributions are broader and could include sore throat, sinusitis, ear pain, and pulmonary fibrosis.”

When asked to assess whether GERD is causing extraesophageal symptoms, consider the “constellation” of patient presentation, test results, and treatment response, according to the clinical practice update. No diagnostic tests “unequivocally link any suspected extraesophageal symptom to GERD.” For patients who have both extraesophageal symptoms and typical symptoms of GERD, the authors suggest an evaluator regimen of 6-8 weeks of empiric, aggressive (twice-daily) proton pump inhibitor (PPI) therapy. If aggressive acid suppression therapy appears to improve extra­esophageal symptoms, patients should be titrated to the lowest effective treatment dose.If symptoms persist despite an aggressive trial of a PPI, and patients have a body mass index under 25, and a seemingly low probability of GERD, then the experts recommend pH testing “off” therapy and seeking other etiologies for extraesophageal symptoms. If symptoms persist and a patients’ BMI exceeds 25 with a high suspicion of GERD, they recommend evaluations for concomitant asthma or lung disease. If these work-ups are positive, they recommend multichannel intraluminal impedance testing or pH monitoring on treatment.

The clinical practice update strongly discourages surgical treatment of extraesophageal GERD symptoms except in specific populations, such as when patients have objective signs of treatment-refractory GERD and have not responded to comprehensive therapy for other possible causes of extraesophageal symptoms. Recent data suggest that surgery can benefit patients with confirmed structural defects, such as hiatal hernia, which are causing symptomatic, volume-based regurgitation, the experts note. Ideally, these patients should first undergo pH and impedance monitoring to objectively measure the effects of reflux. Additionally, surgical fundoplication “might be beneficial” for patients whose extraesophageal symptoms clearly have responded to PPI therapy but who refuse long-term PPI therapy or who develop unacceptable side effects.

The practice update also extensively discusses the role of testing to evaluate the role of GERD in extraesophageal symptoms. Barium esophagography is insensitive for GERD and is useful only for evaluating dysphagia and the size and type of a hiatal hernia, the experts note. Abnormal laryngoscopy or pharyngoscopic findings are more useful but should not be the “initial driving force” behind a GERD diagnosis and do not necessarily link GERD to extraesophageal symptoms. Likewise, esophagogastroduodenoscopy can identify esophagitis, which signifies GERD but does not establish it as etiologic.

Positive ambulatory pH or impedance monitoring or pharyngeal pH tests also do not definitively link reflux to suspected extraesophageal symptoms, the experts note. They suggest considering “on” therapy monitoring to evaluate treatment efficacy and to time reflux events relative to symptoms in patients with esophagitis, Barrett’s esophagus, or a large hiatal hernia. Conversely, they recommend considering “off” treatment testing to rule out GERD in patients who have no history of confirmed or suspected reflux and who have not responded to PPI therapy.

Novel tests, such as salivary pepsin and mucosal impedance, have “no clear role in establishing GERD as the cause of extraesophageal symptoms,” the experts emphasize. Clinician scientists also debate the exact pathophysiology of extraesophageal GERD sequelae. While chronic exposure to gastric refluxate clearly can harm proximal structures such as the pharynx, larynx, and bronchial tree, it remains unclear how much acid is necessary to cause injury and whether bile, pepsin, or neurogenic stimulation play a role.

Dr. Vaezi reported having no conflicts of interest. Senior author Frank Zerbib, MD, PhD, reported receiving devices for research purposes from Medtronic and Sandhill Scientific.
 

SOURCE: Vaezi MF et al. Clin Gastroenterol Hepatol. 2018 Feb 7. doi: 10.1016/j.cgh.2018.02.001.

Primarily home-based cognitive-behavioral therapy improved irritable bowel syndrome symptoms at least as much as conventional CBT, cut clinician time by 60%, and significantly outperformed educational sessions in a multicenter clinical trial reported in the July issue of Gastroenterology.

Acutely, primarily home-based CBT produced a mean 61% improvement in self-reported symptoms on the IBS version of the Clinical Global Impressions Scale, versus 44% for the educational control group (P less than .05), wrote Jeffrey M. Lackner, PsyD, of the State University of New York at Buffalo and his associates. Blinded gastroenterologists reported improvements of 56% and 40%, respectively (P less than .05). The superiority of the minimal-contact CBT program held up at 6 months and equivalence tests found it “at least as effective as standard CBT,” the researchers wrote.

IBS is a major area of unmet clinical need that costs the United States some $28 billion annually. Clinicians and patients lack both reliable biomarkers and “uniformly effective” therapies, the investigators noted. In recent years, severe adverse events have greatly restricted the availability of otherwise promising Food and Drug Administration–approved therapies, such as Lotronex (alosetron hydrochlorine), which has been linked to ischemic colitis and fatal cases of ruptured bowel, and Zelnorm (tegaserod maleate), which has been associated with myocardial infarction, stroke, and unstable angina.

In contrast, face-to-face CBT is safe, efficacious, and guideline recommended for IBS. However, uptake is limited by cost, stigma, geography, and a shortage of certified providers, the researchers noted. They enrolled 436 patients with IBS based on Rome III criteria and randomly assigned them to one of three interventions. The standard CBT group received 10 weekly, 60-minute, face-to-face CBT sessions on brain-gut interactions, symptom triggers and monitoring, muscle relaxation, worry control, problem-solving, and relapse prevention. The primarily home-based CBT group covered the same topics but attended only four clinic sessions and was provided home study materials. Finally, the education group attended four sessions with background information on IBS and the role of stress, diet, and exercise.

Baseline characteristics were comparable among groups, as were dropout rates (9% overall). In all, 89% of patients completed at least 8 of 10 standard cognitive-behavioral therapy sessions or at least three of four home-based CBT or educational sessions. Six months after the interventions ended, primarily home-based CBT continued to outperform education (blinded gastroenterologist-reported improvements, 58.4% and 44.8%, respectively; P = .05 for difference between groups).

Equivalence tests indicated that the minimal-CBT intervention was at least as effective as standard CBT, and improvements were not primarily the result of concomitant medications, according to the researchers. Nonetheless, only 42% of patients who benefited from CBT achieved remission, defined as no or mild IBS symptoms on the gastroenterologist-administered Clinical Global Impressions Scale. Unremitted patients might benefit from combining CBT with medical therapies that target both “central and peripheral mechanisms of IBS,” the investigators said.

The three interventions produced comparable acute and longer-term improvements on the IBS Symptom Severity Scale, which emphasizes sensory symptoms and therefore might be a less sensitive endpoint than the Clinical Global Impressions Scale, the researchers noted. Nonetheless, CBT produced some of the strongest absolute symptomatic improvements ever reported for IBS. “To put these data in context, treatment response of FDA-approved pharmacological agents using global IBS symptom improvement scales range from 17% to 40%,” the researchers wrote.

The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
 

SOURCE: Lackner JM et al. Gastroenterology. 2018 Apr 24. doi: 10.1053/j.gastro.2018.03.063.

Primarily home-based cognitive-behavioral therapy improved irritable bowel syndrome symptoms at least as much as conventional CBT, cut clinician time by 60%, and significantly outperformed educational sessions in a multicenter clinical trial reported in the July issue of Gastroenterology.

Acutely, primarily home-based CBT produced a mean 61% improvement in self-reported symptoms on the IBS version of the Clinical Global Impressions Scale, versus 44% for the educational control group (P less than .05), wrote Jeffrey M. Lackner, PsyD, of the State University of New York at Buffalo and his associates. Blinded gastroenterologists reported improvements of 56% and 40%, respectively (P less than .05). The superiority of the minimal-contact CBT program held up at 6 months and equivalence tests found it “at least as effective as standard CBT,” the researchers wrote.

IBS is a major area of unmet clinical need that costs the United States some $28 billion annually. Clinicians and patients lack both reliable biomarkers and “uniformly effective” therapies, the investigators noted. In recent years, severe adverse events have greatly restricted the availability of otherwise promising Food and Drug Administration–approved therapies, such as Lotronex (alosetron hydrochlorine), which has been linked to ischemic colitis and fatal cases of ruptured bowel, and Zelnorm (tegaserod maleate), which has been associated with myocardial infarction, stroke, and unstable angina.

In contrast, face-to-face CBT is safe, efficacious, and guideline recommended for IBS. However, uptake is limited by cost, stigma, geography, and a shortage of certified providers, the researchers noted. They enrolled 436 patients with IBS based on Rome III criteria and randomly assigned them to one of three interventions. The standard CBT group received 10 weekly, 60-minute, face-to-face CBT sessions on brain-gut interactions, symptom triggers and monitoring, muscle relaxation, worry control, problem-solving, and relapse prevention. The primarily home-based CBT group covered the same topics but attended only four clinic sessions and was provided home study materials. Finally, the education group attended four sessions with background information on IBS and the role of stress, diet, and exercise.

Baseline characteristics were comparable among groups, as were dropout rates (9% overall). In all, 89% of patients completed at least 8 of 10 standard cognitive-behavioral therapy sessions or at least three of four home-based CBT or educational sessions. Six months after the interventions ended, primarily home-based CBT continued to outperform education (blinded gastroenterologist-reported improvements, 58.4% and 44.8%, respectively; P = .05 for difference between groups).

Equivalence tests indicated that the minimal-CBT intervention was at least as effective as standard CBT, and improvements were not primarily the result of concomitant medications, according to the researchers. Nonetheless, only 42% of patients who benefited from CBT achieved remission, defined as no or mild IBS symptoms on the gastroenterologist-administered Clinical Global Impressions Scale. Unremitted patients might benefit from combining CBT with medical therapies that target both “central and peripheral mechanisms of IBS,” the investigators said.

The three interventions produced comparable acute and longer-term improvements on the IBS Symptom Severity Scale, which emphasizes sensory symptoms and therefore might be a less sensitive endpoint than the Clinical Global Impressions Scale, the researchers noted. Nonetheless, CBT produced some of the strongest absolute symptomatic improvements ever reported for IBS. “To put these data in context, treatment response of FDA-approved pharmacological agents using global IBS symptom improvement scales range from 17% to 40%,” the researchers wrote.

The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
 

SOURCE: Lackner JM et al. Gastroenterology. 2018 Apr 24. doi: 10.1053/j.gastro.2018.03.063.

Primarily home-based cognitive-behavioral therapy improved irritable bowel syndrome symptoms at least as much as conventional CBT, cut clinician time by 60%, and significantly outperformed educational sessions in a multicenter clinical trial reported in the July issue of Gastroenterology.

Acutely, primarily home-based CBT produced a mean 61% improvement in self-reported symptoms on the IBS version of the Clinical Global Impressions Scale, versus 44% for the educational control group (P less than .05), wrote Jeffrey M. Lackner, PsyD, of the State University of New York at Buffalo and his associates. Blinded gastroenterologists reported improvements of 56% and 40%, respectively (P less than .05). The superiority of the minimal-contact CBT program held up at 6 months and equivalence tests found it “at least as effective as standard CBT,” the researchers wrote.

IBS is a major area of unmet clinical need that costs the United States some $28 billion annually. Clinicians and patients lack both reliable biomarkers and “uniformly effective” therapies, the investigators noted. In recent years, severe adverse events have greatly restricted the availability of otherwise promising Food and Drug Administration–approved therapies, such as Lotronex (alosetron hydrochlorine), which has been linked to ischemic colitis and fatal cases of ruptured bowel, and Zelnorm (tegaserod maleate), which has been associated with myocardial infarction, stroke, and unstable angina.

In contrast, face-to-face CBT is safe, efficacious, and guideline recommended for IBS. However, uptake is limited by cost, stigma, geography, and a shortage of certified providers, the researchers noted. They enrolled 436 patients with IBS based on Rome III criteria and randomly assigned them to one of three interventions. The standard CBT group received 10 weekly, 60-minute, face-to-face CBT sessions on brain-gut interactions, symptom triggers and monitoring, muscle relaxation, worry control, problem-solving, and relapse prevention. The primarily home-based CBT group covered the same topics but attended only four clinic sessions and was provided home study materials. Finally, the education group attended four sessions with background information on IBS and the role of stress, diet, and exercise.

Baseline characteristics were comparable among groups, as were dropout rates (9% overall). In all, 89% of patients completed at least 8 of 10 standard cognitive-behavioral therapy sessions or at least three of four home-based CBT or educational sessions. Six months after the interventions ended, primarily home-based CBT continued to outperform education (blinded gastroenterologist-reported improvements, 58.4% and 44.8%, respectively; P = .05 for difference between groups).

Equivalence tests indicated that the minimal-CBT intervention was at least as effective as standard CBT, and improvements were not primarily the result of concomitant medications, according to the researchers. Nonetheless, only 42% of patients who benefited from CBT achieved remission, defined as no or mild IBS symptoms on the gastroenterologist-administered Clinical Global Impressions Scale. Unremitted patients might benefit from combining CBT with medical therapies that target both “central and peripheral mechanisms of IBS,” the investigators said.

The three interventions produced comparable acute and longer-term improvements on the IBS Symptom Severity Scale, which emphasizes sensory symptoms and therefore might be a less sensitive endpoint than the Clinical Global Impressions Scale, the researchers noted. Nonetheless, CBT produced some of the strongest absolute symptomatic improvements ever reported for IBS. “To put these data in context, treatment response of FDA-approved pharmacological agents using global IBS symptom improvement scales range from 17% to 40%,” the researchers wrote.

The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
 

SOURCE: Lackner JM et al. Gastroenterology. 2018 Apr 24. doi: 10.1053/j.gastro.2018.03.063.

Older age, male sex, smoking, longer segment length, and low-grade dysplasia were significant risk factors for progression of Barrett’s esophagus in a meta-analysis of 20 studies.

“Individuals with these features should undergo more intensive surveillance or endoscopic therapy,” Rajesh Krishnamoorthi, MD, of Mayo Clinic in Rochester, Minn., and his associates wrote in Clinical Gastroenterology and Hepatology. “Smoking is a modifiable risk factor for cancer prevention in patients with BE.”

“Currently, gastrointestinal societies’ guidelines on BE surveillance are solely based on dysplasia grade and do not take into account any of the other risk factors,” the reviewers concluded. Their findings could form the backbone of a risk score that identifies high-risk BE patients with baseline low-grade dysplasia or nondysplastic BE “who would benefit from intensive surveillance or endoscopic therapy.”

Esophageal adenocarcinoma is on the rise and fewer than one in five patients survive 5 years past diagnosis. Endoscopic surveillance for esophageal adenocarcinoma is recommended in Barrett’s esophagus, but only about one in 10 esophageal adenocarcinoma patients has a preceding BE diagnosis. “This ostensible discrepancy has raised concerns about the effectiveness of current screening and surveillance programs,” the reviewers noted. Studies also have yielded conflicting evidence about the value of endoscopic surveillance as currently performed. To help prioritize BE patients for surveillance, the reviewers searched EMBASE, MEDLINE, and Web of Science from inception through May 2016 for cohort studies of risk factors for progression of BE among patients with either no dysplasia or low-grade dysplasia.

The 20 studies covered 1,231 BE progression events among 74,943 patients. In separate pooled estimates, progression of BE correlated significantly with older age (odds ratio, 1.03; 95% CI, 1.01–1.05), male sex (OR, 2.2; 95% CI, 1.8-2.5), current or former smoking (OR, 1.5; 95% CI, 1.09-2.0), and greater BE segment length (OR, 1.3; 95% CI, 1.16-1.36). Results tended to be homogeneous among studies, said the reviewers. Low-grade dysplasia correlated strongly with progression (OR, 4.3; 95% CI, 2.6-7.0), while use of proton pump inhibitors (OR, 0.55; 95% CI, 0.32–0.96) and statins (OR, 0.48; 95% CI, 0.31-0.73) showed the opposite trend. “Alcohol use and obesity did not associate with risk of progression,” the reviewers added.

Thirteen studies in the meta-analysis were from Europe, six were from the United States, and one was from Australia. Ten were multicenter studies, 13 were deemed high-quality, three were deemed medium-quality, and four were deemed low-quality. The reviewers were unable to assess dose-response relationships for relevant factors, such as alcohol, tobacco, and medications, and not all studies accounted for potential confounding.

Only four studies included multivariate analyses to control for the confounding effects of age, sex, and BE characteristics (length and dysplasia). When the reviewers analyzed only these studies, older age and smoking no longer predicted BE progression. Use of proton pump inhibitors remained protective, and use of nonsteroidal anti-inflammatory drugs (NSAIDs) became protective, while statin use lost significance.

The reviewers disclosed no external funding sources or conflicts of interest.

SOURCE: Krishnamoorthi R, et al. Clinical Gastroenterol and Hepatol. 2017 Nov 30. doi: 10.1016/j.cgh.2017.11.044

Older age, male sex, smoking, longer segment length, and low-grade dysplasia were significant risk factors for progression of Barrett’s esophagus in a meta-analysis of 20 studies.

“Individuals with these features should undergo more intensive surveillance or endoscopic therapy,” Rajesh Krishnamoorthi, MD, of Mayo Clinic in Rochester, Minn., and his associates wrote in Clinical Gastroenterology and Hepatology. “Smoking is a modifiable risk factor for cancer prevention in patients with BE.”

“Currently, gastrointestinal societies’ guidelines on BE surveillance are solely based on dysplasia grade and do not take into account any of the other risk factors,” the reviewers concluded. Their findings could form the backbone of a risk score that identifies high-risk BE patients with baseline low-grade dysplasia or nondysplastic BE “who would benefit from intensive surveillance or endoscopic therapy.”

Esophageal adenocarcinoma is on the rise and fewer than one in five patients survive 5 years past diagnosis. Endoscopic surveillance for esophageal adenocarcinoma is recommended in Barrett’s esophagus, but only about one in 10 esophageal adenocarcinoma patients has a preceding BE diagnosis. “This ostensible discrepancy has raised concerns about the effectiveness of current screening and surveillance programs,” the reviewers noted. Studies also have yielded conflicting evidence about the value of endoscopic surveillance as currently performed. To help prioritize BE patients for surveillance, the reviewers searched EMBASE, MEDLINE, and Web of Science from inception through May 2016 for cohort studies of risk factors for progression of BE among patients with either no dysplasia or low-grade dysplasia.

The 20 studies covered 1,231 BE progression events among 74,943 patients. In separate pooled estimates, progression of BE correlated significantly with older age (odds ratio, 1.03; 95% CI, 1.01–1.05), male sex (OR, 2.2; 95% CI, 1.8-2.5), current or former smoking (OR, 1.5; 95% CI, 1.09-2.0), and greater BE segment length (OR, 1.3; 95% CI, 1.16-1.36). Results tended to be homogeneous among studies, said the reviewers. Low-grade dysplasia correlated strongly with progression (OR, 4.3; 95% CI, 2.6-7.0), while use of proton pump inhibitors (OR, 0.55; 95% CI, 0.32–0.96) and statins (OR, 0.48; 95% CI, 0.31-0.73) showed the opposite trend. “Alcohol use and obesity did not associate with risk of progression,” the reviewers added.

Thirteen studies in the meta-analysis were from Europe, six were from the United States, and one was from Australia. Ten were multicenter studies, 13 were deemed high-quality, three were deemed medium-quality, and four were deemed low-quality. The reviewers were unable to assess dose-response relationships for relevant factors, such as alcohol, tobacco, and medications, and not all studies accounted for potential confounding.

Only four studies included multivariate analyses to control for the confounding effects of age, sex, and BE characteristics (length and dysplasia). When the reviewers analyzed only these studies, older age and smoking no longer predicted BE progression. Use of proton pump inhibitors remained protective, and use of nonsteroidal anti-inflammatory drugs (NSAIDs) became protective, while statin use lost significance.

The reviewers disclosed no external funding sources or conflicts of interest.

SOURCE: Krishnamoorthi R, et al. Clinical Gastroenterol and Hepatol. 2017 Nov 30. doi: 10.1016/j.cgh.2017.11.044

Older age, male sex, smoking, longer segment length, and low-grade dysplasia were significant risk factors for progression of Barrett’s esophagus in a meta-analysis of 20 studies.

“Individuals with these features should undergo more intensive surveillance or endoscopic therapy,” Rajesh Krishnamoorthi, MD, of Mayo Clinic in Rochester, Minn., and his associates wrote in Clinical Gastroenterology and Hepatology. “Smoking is a modifiable risk factor for cancer prevention in patients with BE.”

“Currently, gastrointestinal societies’ guidelines on BE surveillance are solely based on dysplasia grade and do not take into account any of the other risk factors,” the reviewers concluded. Their findings could form the backbone of a risk score that identifies high-risk BE patients with baseline low-grade dysplasia or nondysplastic BE “who would benefit from intensive surveillance or endoscopic therapy.”

Esophageal adenocarcinoma is on the rise and fewer than one in five patients survive 5 years past diagnosis. Endoscopic surveillance for esophageal adenocarcinoma is recommended in Barrett’s esophagus, but only about one in 10 esophageal adenocarcinoma patients has a preceding BE diagnosis. “This ostensible discrepancy has raised concerns about the effectiveness of current screening and surveillance programs,” the reviewers noted. Studies also have yielded conflicting evidence about the value of endoscopic surveillance as currently performed. To help prioritize BE patients for surveillance, the reviewers searched EMBASE, MEDLINE, and Web of Science from inception through May 2016 for cohort studies of risk factors for progression of BE among patients with either no dysplasia or low-grade dysplasia.

The 20 studies covered 1,231 BE progression events among 74,943 patients. In separate pooled estimates, progression of BE correlated significantly with older age (odds ratio, 1.03; 95% CI, 1.01–1.05), male sex (OR, 2.2; 95% CI, 1.8-2.5), current or former smoking (OR, 1.5; 95% CI, 1.09-2.0), and greater BE segment length (OR, 1.3; 95% CI, 1.16-1.36). Results tended to be homogeneous among studies, said the reviewers. Low-grade dysplasia correlated strongly with progression (OR, 4.3; 95% CI, 2.6-7.0), while use of proton pump inhibitors (OR, 0.55; 95% CI, 0.32–0.96) and statins (OR, 0.48; 95% CI, 0.31-0.73) showed the opposite trend. “Alcohol use and obesity did not associate with risk of progression,” the reviewers added.

Thirteen studies in the meta-analysis were from Europe, six were from the United States, and one was from Australia. Ten were multicenter studies, 13 were deemed high-quality, three were deemed medium-quality, and four were deemed low-quality. The reviewers were unable to assess dose-response relationships for relevant factors, such as alcohol, tobacco, and medications, and not all studies accounted for potential confounding.

Only four studies included multivariate analyses to control for the confounding effects of age, sex, and BE characteristics (length and dysplasia). When the reviewers analyzed only these studies, older age and smoking no longer predicted BE progression. Use of proton pump inhibitors remained protective, and use of nonsteroidal anti-inflammatory drugs (NSAIDs) became protective, while statin use lost significance.

The reviewers disclosed no external funding sources or conflicts of interest.

SOURCE: Krishnamoorthi R, et al. Clinical Gastroenterol and Hepatol. 2017 Nov 30. doi: 10.1016/j.cgh.2017.11.044