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Enlarging Mass on the Lateral Neck
Branchial Cleft Cyst
Cystic lesions present in a myriad of ways and often require histopathologic examination for definitive diagnosis. Correct identification of the cells comprising the lining of the cyst and the composition of the surrounding tissue are utilized to classify these lesions.
Branchial cleft cysts (quiz image, Figure 1) most commonly present as a soft tissue swelling of the lateral neck anterior to the sternocleidomastoid; they also can present in the preauricular or mandibular region.1,2 Although the cyst is present at birth, it typically is not clinically apparent until the second or third decades of life. The origin of branchial cleft cysts is subject to some debate; however, the prevailing theory is that they result from failure of obliteration of the second branchial arch during development.1 Histopathologically, branchial cleft cysts are characterized by a stratified squamous epithelial lining and abundant lymphoid tissue with germinal centers.3,4 Infection is a common reason for presentation and excision is curative.
Bronchogenic cysts (Figure 2) present as midline lesions in the suprasternal notch and can present clinically due to compression of the airway.5 They develop as anomalies of the primitive foregut, budding off of the tracheobronchial tree. Similar to respiratory tissue, they are lined with a ciliated pseudostratified columnar epithelium and contain goblet cells. Concentric smooth muscle often surrounds the cyst and cartilage may be present.4 Excision is curative and recommended if the cyst encroaches on vital structures.
Median raphe cysts occur most commonly on the ventral surface of the penis on or near the glans (Figure 3). These cysts are thought to result from anomalous budding from the urethral epithelium, though they do not maintain contact with the urethra.3 The lining varies in thickness from 1 to 4 cell layers and mimics the transitional epithelium of the urethra. Amorphous debris often is seen within the cyst, and surrounding genital tissue can be appreciated by identification of delicate collagen, smooth muscle, and numerous small nerves and vessels.3,4 Excision is curative and often is sought when the cyst becomes irritated or cosmetically bothersome.
Steatocystomas can present as solitary (steatocystoma simplex) or multiple lesions (steatocystoma multiplex)(Figure 4). They present as small, well-defined, yellow cystic papules most commonly on the chest, axilla, or groin.2 Their lining is composed of a stratified squamous epithelium that lacks a granular layer and contains a distinct overlying corrugated "shark tooth" eosinophilic cuticle. Sebaceous lobules are characteristically present along or within the cyst wall.3,4 Excision is curative and treatment often is sought for cosmetic purposes.
Similar to bronchogenic cysts, thyroglossal duct cysts (Figure 5) present on the midline neck, though they characteristically move with swallowing. The thyroglossal duct develops as the thyroid migrates from the floor of the pharynx to the anterior neck. Remnants of this duct result in the thyroglossal duct cyst.2 These cysts contain a respiratory-type epithelial lining and are distinguished by distinct thyroid follicles and lymphoid aggregates surrounding the cyst wall. Unlike bronchogenic cysts, they do not contain smooth muscle.3,4 Excision is curative.
- Chavan S, Deshmukh R, Karande P, et al. Branchial cleft cyst: a case report and review of literature. J Oral Maxillofac Pathol. 2014;18:150.
- Stone MS. Cysts. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. Vol 2. 3rd ed. Philadelphia, PA: Elsevier/Saunders; 2012:1817-1828.
- Kirkham N, Aljefri K. Tumors and cysts of the epidermis. In: Elder DE, Elenitsas R, Rosenbach M, et al, eds. Lever's Histopathology of the Skin. 11th ed. Philadelphia, PA: Wolters Kluwer; 2015:969-1024.
- Elston DM. Benign tumors and cysts of the epidermis. In: Elston DM, Ferringer T, et al. Dermatopathology. 2nd ed. Philadelphia, PA: Elsevier/Saunders; 2014:49-55.
- Hsu CG, Heller M, Johnston GS, et al. An unusual cause of airway compromise in the emergency department: mediastinal bronchogenic cyst [published online December 13, 2016]. J Emerg Med. 2017;52:E91-E93.
Branchial Cleft Cyst
Cystic lesions present in a myriad of ways and often require histopathologic examination for definitive diagnosis. Correct identification of the cells comprising the lining of the cyst and the composition of the surrounding tissue are utilized to classify these lesions.
Branchial cleft cysts (quiz image, Figure 1) most commonly present as a soft tissue swelling of the lateral neck anterior to the sternocleidomastoid; they also can present in the preauricular or mandibular region.1,2 Although the cyst is present at birth, it typically is not clinically apparent until the second or third decades of life. The origin of branchial cleft cysts is subject to some debate; however, the prevailing theory is that they result from failure of obliteration of the second branchial arch during development.1 Histopathologically, branchial cleft cysts are characterized by a stratified squamous epithelial lining and abundant lymphoid tissue with germinal centers.3,4 Infection is a common reason for presentation and excision is curative.
Bronchogenic cysts (Figure 2) present as midline lesions in the suprasternal notch and can present clinically due to compression of the airway.5 They develop as anomalies of the primitive foregut, budding off of the tracheobronchial tree. Similar to respiratory tissue, they are lined with a ciliated pseudostratified columnar epithelium and contain goblet cells. Concentric smooth muscle often surrounds the cyst and cartilage may be present.4 Excision is curative and recommended if the cyst encroaches on vital structures.
Median raphe cysts occur most commonly on the ventral surface of the penis on or near the glans (Figure 3). These cysts are thought to result from anomalous budding from the urethral epithelium, though they do not maintain contact with the urethra.3 The lining varies in thickness from 1 to 4 cell layers and mimics the transitional epithelium of the urethra. Amorphous debris often is seen within the cyst, and surrounding genital tissue can be appreciated by identification of delicate collagen, smooth muscle, and numerous small nerves and vessels.3,4 Excision is curative and often is sought when the cyst becomes irritated or cosmetically bothersome.
Steatocystomas can present as solitary (steatocystoma simplex) or multiple lesions (steatocystoma multiplex)(Figure 4). They present as small, well-defined, yellow cystic papules most commonly on the chest, axilla, or groin.2 Their lining is composed of a stratified squamous epithelium that lacks a granular layer and contains a distinct overlying corrugated "shark tooth" eosinophilic cuticle. Sebaceous lobules are characteristically present along or within the cyst wall.3,4 Excision is curative and treatment often is sought for cosmetic purposes.
Similar to bronchogenic cysts, thyroglossal duct cysts (Figure 5) present on the midline neck, though they characteristically move with swallowing. The thyroglossal duct develops as the thyroid migrates from the floor of the pharynx to the anterior neck. Remnants of this duct result in the thyroglossal duct cyst.2 These cysts contain a respiratory-type epithelial lining and are distinguished by distinct thyroid follicles and lymphoid aggregates surrounding the cyst wall. Unlike bronchogenic cysts, they do not contain smooth muscle.3,4 Excision is curative.
Branchial Cleft Cyst
Cystic lesions present in a myriad of ways and often require histopathologic examination for definitive diagnosis. Correct identification of the cells comprising the lining of the cyst and the composition of the surrounding tissue are utilized to classify these lesions.
Branchial cleft cysts (quiz image, Figure 1) most commonly present as a soft tissue swelling of the lateral neck anterior to the sternocleidomastoid; they also can present in the preauricular or mandibular region.1,2 Although the cyst is present at birth, it typically is not clinically apparent until the second or third decades of life. The origin of branchial cleft cysts is subject to some debate; however, the prevailing theory is that they result from failure of obliteration of the second branchial arch during development.1 Histopathologically, branchial cleft cysts are characterized by a stratified squamous epithelial lining and abundant lymphoid tissue with germinal centers.3,4 Infection is a common reason for presentation and excision is curative.
Bronchogenic cysts (Figure 2) present as midline lesions in the suprasternal notch and can present clinically due to compression of the airway.5 They develop as anomalies of the primitive foregut, budding off of the tracheobronchial tree. Similar to respiratory tissue, they are lined with a ciliated pseudostratified columnar epithelium and contain goblet cells. Concentric smooth muscle often surrounds the cyst and cartilage may be present.4 Excision is curative and recommended if the cyst encroaches on vital structures.
Median raphe cysts occur most commonly on the ventral surface of the penis on or near the glans (Figure 3). These cysts are thought to result from anomalous budding from the urethral epithelium, though they do not maintain contact with the urethra.3 The lining varies in thickness from 1 to 4 cell layers and mimics the transitional epithelium of the urethra. Amorphous debris often is seen within the cyst, and surrounding genital tissue can be appreciated by identification of delicate collagen, smooth muscle, and numerous small nerves and vessels.3,4 Excision is curative and often is sought when the cyst becomes irritated or cosmetically bothersome.
Steatocystomas can present as solitary (steatocystoma simplex) or multiple lesions (steatocystoma multiplex)(Figure 4). They present as small, well-defined, yellow cystic papules most commonly on the chest, axilla, or groin.2 Their lining is composed of a stratified squamous epithelium that lacks a granular layer and contains a distinct overlying corrugated "shark tooth" eosinophilic cuticle. Sebaceous lobules are characteristically present along or within the cyst wall.3,4 Excision is curative and treatment often is sought for cosmetic purposes.
Similar to bronchogenic cysts, thyroglossal duct cysts (Figure 5) present on the midline neck, though they characteristically move with swallowing. The thyroglossal duct develops as the thyroid migrates from the floor of the pharynx to the anterior neck. Remnants of this duct result in the thyroglossal duct cyst.2 These cysts contain a respiratory-type epithelial lining and are distinguished by distinct thyroid follicles and lymphoid aggregates surrounding the cyst wall. Unlike bronchogenic cysts, they do not contain smooth muscle.3,4 Excision is curative.
- Chavan S, Deshmukh R, Karande P, et al. Branchial cleft cyst: a case report and review of literature. J Oral Maxillofac Pathol. 2014;18:150.
- Stone MS. Cysts. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. Vol 2. 3rd ed. Philadelphia, PA: Elsevier/Saunders; 2012:1817-1828.
- Kirkham N, Aljefri K. Tumors and cysts of the epidermis. In: Elder DE, Elenitsas R, Rosenbach M, et al, eds. Lever's Histopathology of the Skin. 11th ed. Philadelphia, PA: Wolters Kluwer; 2015:969-1024.
- Elston DM. Benign tumors and cysts of the epidermis. In: Elston DM, Ferringer T, et al. Dermatopathology. 2nd ed. Philadelphia, PA: Elsevier/Saunders; 2014:49-55.
- Hsu CG, Heller M, Johnston GS, et al. An unusual cause of airway compromise in the emergency department: mediastinal bronchogenic cyst [published online December 13, 2016]. J Emerg Med. 2017;52:E91-E93.
- Chavan S, Deshmukh R, Karande P, et al. Branchial cleft cyst: a case report and review of literature. J Oral Maxillofac Pathol. 2014;18:150.
- Stone MS. Cysts. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. Vol 2. 3rd ed. Philadelphia, PA: Elsevier/Saunders; 2012:1817-1828.
- Kirkham N, Aljefri K. Tumors and cysts of the epidermis. In: Elder DE, Elenitsas R, Rosenbach M, et al, eds. Lever's Histopathology of the Skin. 11th ed. Philadelphia, PA: Wolters Kluwer; 2015:969-1024.
- Elston DM. Benign tumors and cysts of the epidermis. In: Elston DM, Ferringer T, et al. Dermatopathology. 2nd ed. Philadelphia, PA: Elsevier/Saunders; 2014:49-55.
- Hsu CG, Heller M, Johnston GS, et al. An unusual cause of airway compromise in the emergency department: mediastinal bronchogenic cyst [published online December 13, 2016]. J Emerg Med. 2017;52:E91-E93.
A 14-year-old adolescent boy presented with a nontender mass on the left lateral neck. The mass had been present since birth but had recently grown in size.
EC approves pembrolizumab for cHL patients
The European Commission (EC) has approved the anti-PD-1 therapy pembrolizumab (Keytruda) for use in patients with classical Hodgkin lymphoma (cHL).
The drug is now approved to treat adults with relapsed or refractory cHL who have failed autologous stem cell transplant (auto-SCT) and brentuximab vedotin (BV) or who are transplant-ineligible and have failed treatment with BV.
The approval allows marketing of pembrolizumab for this indication in the European Economic Area (EEA).
This is the first approval for pembrolizumab in a hematologic malignancy in the EEA. The drug was previously approved there as a treatment for melanoma and non-small-cell lung cancer.
The new approval for pembrolizumab was based on data from the KEYNOTE-087 and KEYNOTE-013 trials.
Results from KEYNOTE-013 were presented at the 2016 ASH Annual Meeting (abstract 1108), and results from KEYNOTE-087 were recently published in the Journal of Clinical Oncology.
KEYNOTE-087
In this phase 2 trial, researchers evaluated pembrolizumab (a 200 mg fixed dose every 3 weeks) in patients with relapsed or refractory cHL across 3 cohorts:
- Cohort 1: Patients who progressed after auto-HSCT and subsequent treatment with BV
- Cohort 2: Patients who failed salvage chemotherapy, were ineligible for a transplant, and progressed after BV
- Cohort 3: Patients who progressed after auto-HSCT and did not receive BV after transplant.
Across all 210 enrolled patients, the overall response rate (ORR) was 69.0%, and the complete response (CR) rate was 22.4%.
In Cohort 1 (n=69), the ORR was 73.9%, and the CR rate was 21.7%.
In Cohort 2 (n=81), the ORR was 64.2%, and the CR rate was 24.7%.
In Cohort 3 (n=60), the ORR was 70.0%, and the CR rate was 20%.
For the entire study cohort, the median duration of response was not reached, and the median overall survival (OS) was not reached. At 9 months, the OS was 97.5%, and the progression-free survival (PFS) was 63.4%.
The most common treatment-related adverse events (AEs) were hypothyroidism (12.4%), pyrexia (10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%), nausea (5.7%), cough (5.7%), and neutropenia (5.2%).
The most common grade 3/4 treatment-related AEs were neutropenia (2.4%), diarrhea (1.0%), and dyspnea (1.0%). Immune-mediated AEs included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%), and myositis (1.0%).
There were 9 discontinuations because of treatment-related AEs and no treatment-related deaths.
KEYNOTE-013
KEYNOTE-013 is a phase 1b trial that has enrolled 31 patients with relapsed or refractory cHL who failed auto-HSCT and subsequent BV or who were transplant-ineligible.
Patients received pembrolizumab at 10 mg/kg every 2 weeks. The median duration of follow-up was 29 months.
The ORR was 58%, and the CR rate was 19%. The median duration of response had not been reached at last follow-up (range, 0.0+ to 26.1+ months), and 70% of responding patients had a response lasting 12 months or more.
The median PFS was 11.4 months (range, 4.9-27.8 months). The 6-month PFS rate was 66%, and the 12-month PFS rate was 48%.
The median OS was not reached. Six-month and 12-month OS rates were 100% and 87%, respectively.
The most common treatment-related AEs were diarrhea (19%), hypothyroidism (13%), pneumonitis (13%), nausea (13%), fatigue (10%), and dyspnea (10%).
The most common grade 3/4 treatment-related AEs were colitis (3%), axillary pain (3%), AST increase (3%), joint swelling (3%), nephrotic syndrome back pain (3%), and dyspnea (3%).
AEs leading to discontinuation were nephrotic syndrome (grade 3), interstitial lung disease (grade 2), and pneumonitis (grade 2). There were no treatment-related deaths. 
The European Commission (EC) has approved the anti-PD-1 therapy pembrolizumab (Keytruda) for use in patients with classical Hodgkin lymphoma (cHL).
The drug is now approved to treat adults with relapsed or refractory cHL who have failed autologous stem cell transplant (auto-SCT) and brentuximab vedotin (BV) or who are transplant-ineligible and have failed treatment with BV.
The approval allows marketing of pembrolizumab for this indication in the European Economic Area (EEA).
This is the first approval for pembrolizumab in a hematologic malignancy in the EEA. The drug was previously approved there as a treatment for melanoma and non-small-cell lung cancer.
The new approval for pembrolizumab was based on data from the KEYNOTE-087 and KEYNOTE-013 trials.
Results from KEYNOTE-013 were presented at the 2016 ASH Annual Meeting (abstract 1108), and results from KEYNOTE-087 were recently published in the Journal of Clinical Oncology.
KEYNOTE-087
In this phase 2 trial, researchers evaluated pembrolizumab (a 200 mg fixed dose every 3 weeks) in patients with relapsed or refractory cHL across 3 cohorts:
- Cohort 1: Patients who progressed after auto-HSCT and subsequent treatment with BV
- Cohort 2: Patients who failed salvage chemotherapy, were ineligible for a transplant, and progressed after BV
- Cohort 3: Patients who progressed after auto-HSCT and did not receive BV after transplant.
Across all 210 enrolled patients, the overall response rate (ORR) was 69.0%, and the complete response (CR) rate was 22.4%.
In Cohort 1 (n=69), the ORR was 73.9%, and the CR rate was 21.7%.
In Cohort 2 (n=81), the ORR was 64.2%, and the CR rate was 24.7%.
In Cohort 3 (n=60), the ORR was 70.0%, and the CR rate was 20%.
For the entire study cohort, the median duration of response was not reached, and the median overall survival (OS) was not reached. At 9 months, the OS was 97.5%, and the progression-free survival (PFS) was 63.4%.
The most common treatment-related adverse events (AEs) were hypothyroidism (12.4%), pyrexia (10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%), nausea (5.7%), cough (5.7%), and neutropenia (5.2%).
The most common grade 3/4 treatment-related AEs were neutropenia (2.4%), diarrhea (1.0%), and dyspnea (1.0%). Immune-mediated AEs included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%), and myositis (1.0%).
There were 9 discontinuations because of treatment-related AEs and no treatment-related deaths.
KEYNOTE-013
KEYNOTE-013 is a phase 1b trial that has enrolled 31 patients with relapsed or refractory cHL who failed auto-HSCT and subsequent BV or who were transplant-ineligible.
Patients received pembrolizumab at 10 mg/kg every 2 weeks. The median duration of follow-up was 29 months.
The ORR was 58%, and the CR rate was 19%. The median duration of response had not been reached at last follow-up (range, 0.0+ to 26.1+ months), and 70% of responding patients had a response lasting 12 months or more.
The median PFS was 11.4 months (range, 4.9-27.8 months). The 6-month PFS rate was 66%, and the 12-month PFS rate was 48%.
The median OS was not reached. Six-month and 12-month OS rates were 100% and 87%, respectively.
The most common treatment-related AEs were diarrhea (19%), hypothyroidism (13%), pneumonitis (13%), nausea (13%), fatigue (10%), and dyspnea (10%).
The most common grade 3/4 treatment-related AEs were colitis (3%), axillary pain (3%), AST increase (3%), joint swelling (3%), nephrotic syndrome back pain (3%), and dyspnea (3%).
AEs leading to discontinuation were nephrotic syndrome (grade 3), interstitial lung disease (grade 2), and pneumonitis (grade 2). There were no treatment-related deaths.
The European Commission (EC) has approved the anti-PD-1 therapy pembrolizumab (Keytruda) for use in patients with classical Hodgkin lymphoma (cHL).
The drug is now approved to treat adults with relapsed or refractory cHL who have failed autologous stem cell transplant (auto-SCT) and brentuximab vedotin (BV) or who are transplant-ineligible and have failed treatment with BV.
The approval allows marketing of pembrolizumab for this indication in the European Economic Area (EEA).
This is the first approval for pembrolizumab in a hematologic malignancy in the EEA. The drug was previously approved there as a treatment for melanoma and non-small-cell lung cancer.
The new approval for pembrolizumab was based on data from the KEYNOTE-087 and KEYNOTE-013 trials.
Results from KEYNOTE-013 were presented at the 2016 ASH Annual Meeting (abstract 1108), and results from KEYNOTE-087 were recently published in the Journal of Clinical Oncology.
KEYNOTE-087
In this phase 2 trial, researchers evaluated pembrolizumab (a 200 mg fixed dose every 3 weeks) in patients with relapsed or refractory cHL across 3 cohorts:
- Cohort 1: Patients who progressed after auto-HSCT and subsequent treatment with BV
- Cohort 2: Patients who failed salvage chemotherapy, were ineligible for a transplant, and progressed after BV
- Cohort 3: Patients who progressed after auto-HSCT and did not receive BV after transplant.
Across all 210 enrolled patients, the overall response rate (ORR) was 69.0%, and the complete response (CR) rate was 22.4%.
In Cohort 1 (n=69), the ORR was 73.9%, and the CR rate was 21.7%.
In Cohort 2 (n=81), the ORR was 64.2%, and the CR rate was 24.7%.
In Cohort 3 (n=60), the ORR was 70.0%, and the CR rate was 20%.
For the entire study cohort, the median duration of response was not reached, and the median overall survival (OS) was not reached. At 9 months, the OS was 97.5%, and the progression-free survival (PFS) was 63.4%.
The most common treatment-related adverse events (AEs) were hypothyroidism (12.4%), pyrexia (10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%), nausea (5.7%), cough (5.7%), and neutropenia (5.2%).
The most common grade 3/4 treatment-related AEs were neutropenia (2.4%), diarrhea (1.0%), and dyspnea (1.0%). Immune-mediated AEs included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%), and myositis (1.0%).
There were 9 discontinuations because of treatment-related AEs and no treatment-related deaths.
KEYNOTE-013
KEYNOTE-013 is a phase 1b trial that has enrolled 31 patients with relapsed or refractory cHL who failed auto-HSCT and subsequent BV or who were transplant-ineligible.
Patients received pembrolizumab at 10 mg/kg every 2 weeks. The median duration of follow-up was 29 months.
The ORR was 58%, and the CR rate was 19%. The median duration of response had not been reached at last follow-up (range, 0.0+ to 26.1+ months), and 70% of responding patients had a response lasting 12 months or more.
The median PFS was 11.4 months (range, 4.9-27.8 months). The 6-month PFS rate was 66%, and the 12-month PFS rate was 48%.
The median OS was not reached. Six-month and 12-month OS rates were 100% and 87%, respectively.
The most common treatment-related AEs were diarrhea (19%), hypothyroidism (13%), pneumonitis (13%), nausea (13%), fatigue (10%), and dyspnea (10%).
The most common grade 3/4 treatment-related AEs were colitis (3%), axillary pain (3%), AST increase (3%), joint swelling (3%), nephrotic syndrome back pain (3%), and dyspnea (3%).
AEs leading to discontinuation were nephrotic syndrome (grade 3), interstitial lung disease (grade 2), and pneumonitis (grade 2). There were no treatment-related deaths.
OR staff perception of safety linked to better surgical outcomes
PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.
“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.
The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.
The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.
The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.
“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”
Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).
Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.
In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.
“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”
Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.
“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.
The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.
The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.
The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.
“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”
Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).
Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.
In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.
“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”
Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.
“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.
The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.
The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.
The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.
“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”
Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).
Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.
In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.
“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”
Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
Key clinical point: Perceptions of safety among operating room personnel may influence postoperative death rates.
Major finding: Higher scores for key teamwork variables were associated with decreases in postoperative hospital death rates ranging from 14% to 29%.
Data source: Survey responses of 1,793 operating room personnel at 31 member hospitals of the South Carolina Hospital Association.
Disclosures: Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.
Male vs. female hospitalists, a comparison in mortality and readmission rate for Medicare patients
CLINICAL QUESTION: Does physician sex affect hospitalized patient outcomes?
BACKGROUND: Previous studies had suggested different practice patterns between male and female physicians in process measure of quality. No prior evaluation of patient outcomes examining those differences was studied in the past.
STUDY DESIGN: Observational, cross-sectional study.
SYNOPSIS: This observational study assessed the difference in patients’ outcomes that were treated by a male or female physician. 30-days mortality rate was analyzed from 1,583,028 hospitalizations. The mortality rate of patients cared for by female physicians was lower and statistically significant: 11.07% vs. 11.49% (adjusted risk difference, –0.43%; 95% CI, –0.57% to –0.28%; P less than .001). The difference did not change after considering patient and physician characteristics as well as when looking at hospital fixed effects (that is, hospital indicators). In order to prevent one death, a female physician needs to treat 233 patients.
Also, 30-day readmission rate, after adjustment readmissions (from 1,540,797 hospitalizations) was 15.02% vs. 15.57% (adjusted risk difference, –0.55%; 95% confidence interval, –0.71% to 0.39%; P less than .001) showing that the care provided by a female physician can reduce one readmission when treating 182 patients.
BOTTOM LINE: Patients older than 65 years have lower 30-day mortality and readmission rates when receiving inpatient care from a female internist, compared with care by a male internist.
CITATIONS: Tsugawa Y, Jena AB, Figueroa JF, et al. Comparison of hospital mortality and readmission rates for Medicare patients treated by male vs. female physicians. JAMA Intern Med. 2017 Feb;177(2):206-13.
Dr. Orjuela is assistant professor of neurology at the University of Colorado School of Medicine, Aurora.
CLINICAL QUESTION: Does physician sex affect hospitalized patient outcomes?
BACKGROUND: Previous studies had suggested different practice patterns between male and female physicians in process measure of quality. No prior evaluation of patient outcomes examining those differences was studied in the past.
STUDY DESIGN: Observational, cross-sectional study.
SYNOPSIS: This observational study assessed the difference in patients’ outcomes that were treated by a male or female physician. 30-days mortality rate was analyzed from 1,583,028 hospitalizations. The mortality rate of patients cared for by female physicians was lower and statistically significant: 11.07% vs. 11.49% (adjusted risk difference, –0.43%; 95% CI, –0.57% to –0.28%; P less than .001). The difference did not change after considering patient and physician characteristics as well as when looking at hospital fixed effects (that is, hospital indicators). In order to prevent one death, a female physician needs to treat 233 patients.
Also, 30-day readmission rate, after adjustment readmissions (from 1,540,797 hospitalizations) was 15.02% vs. 15.57% (adjusted risk difference, –0.55%; 95% confidence interval, –0.71% to 0.39%; P less than .001) showing that the care provided by a female physician can reduce one readmission when treating 182 patients.
BOTTOM LINE: Patients older than 65 years have lower 30-day mortality and readmission rates when receiving inpatient care from a female internist, compared with care by a male internist.
CITATIONS: Tsugawa Y, Jena AB, Figueroa JF, et al. Comparison of hospital mortality and readmission rates for Medicare patients treated by male vs. female physicians. JAMA Intern Med. 2017 Feb;177(2):206-13.
Dr. Orjuela is assistant professor of neurology at the University of Colorado School of Medicine, Aurora.
CLINICAL QUESTION: Does physician sex affect hospitalized patient outcomes?
BACKGROUND: Previous studies had suggested different practice patterns between male and female physicians in process measure of quality. No prior evaluation of patient outcomes examining those differences was studied in the past.
STUDY DESIGN: Observational, cross-sectional study.
SYNOPSIS: This observational study assessed the difference in patients’ outcomes that were treated by a male or female physician. 30-days mortality rate was analyzed from 1,583,028 hospitalizations. The mortality rate of patients cared for by female physicians was lower and statistically significant: 11.07% vs. 11.49% (adjusted risk difference, –0.43%; 95% CI, –0.57% to –0.28%; P less than .001). The difference did not change after considering patient and physician characteristics as well as when looking at hospital fixed effects (that is, hospital indicators). In order to prevent one death, a female physician needs to treat 233 patients.
Also, 30-day readmission rate, after adjustment readmissions (from 1,540,797 hospitalizations) was 15.02% vs. 15.57% (adjusted risk difference, –0.55%; 95% confidence interval, –0.71% to 0.39%; P less than .001) showing that the care provided by a female physician can reduce one readmission when treating 182 patients.
BOTTOM LINE: Patients older than 65 years have lower 30-day mortality and readmission rates when receiving inpatient care from a female internist, compared with care by a male internist.
CITATIONS: Tsugawa Y, Jena AB, Figueroa JF, et al. Comparison of hospital mortality and readmission rates for Medicare patients treated by male vs. female physicians. JAMA Intern Med. 2017 Feb;177(2):206-13.
Dr. Orjuela is assistant professor of neurology at the University of Colorado School of Medicine, Aurora.
End-of-rotation resident transition in care and mortality among hospitalized patients
CLINICAL QUESTION: Are hospitalized patients experiencing an increased mortality risk at the end-rotation resident transition in care and is this association related to the Accreditation Council for Graduate Medical Education (ACGME) 2011 duty-hour regulations?
BACKGROUND: Prior studies of physicians’ transitions in care were associated with potential adverse patient events and outcomes. A higher mortality risk was suggested among patients with a complex hospital course or prolonged length of stay in association to house-staff transitions of care.
SETTING: 10 University-affiliated U.S. Veterans Health Administration hospitals.
SYNOPSIS: 230,701 patient discharges (mean age, 65.6 years; 95.8% male sex; median length of stay, 3 days) were included. The transition group included patients admitted at any time prior to an end-of-rotation who were either discharged or deceased within 7 days of transition. All other discharges were considered controls.
The primary outcome was in-hospital mortality rate; secondary outcomes included 30-day and 90-day mortality and readmission rates. An absolute increase of 1.5% to 1.9% in a unadjusted in-hospitality risk was found. The 30-day and 90-day mortality odds ratios were 1.10 and 1.21, respectively. A possible stronger association was found among interns’ transitions in care and the in-hospital and after-discharge mortality post-ACGME 2011 duty hour regulations. The latter raises questions about the interns’ inexperience and their amount of shift-to-shift handoffs. An adjusted analysis of the readmission rates at 30-day and 90-day was not significantly different between transition vs. control patients.
BOTTOM LINE: Elevated in-hospital mortality was seen among patients admitted to the inpatient medicine service at the end-of-rotation resident transitions in care. The association was stronger after the duty-hour ACGME (2011) regulations.
CITATIONS: Denson JL, Jensen A, Saag HS, et al. Association between end-of-rotation resident transition in care and mortality among hospitalized patients. JAMA. 2016 Dec 6;316(21):2204-13.
Dr. Orjuela is assistant professor of neurology at the University of Colorado School of Medicine, Aurora
CLINICAL QUESTION: Are hospitalized patients experiencing an increased mortality risk at the end-rotation resident transition in care and is this association related to the Accreditation Council for Graduate Medical Education (ACGME) 2011 duty-hour regulations?
BACKGROUND: Prior studies of physicians’ transitions in care were associated with potential adverse patient events and outcomes. A higher mortality risk was suggested among patients with a complex hospital course or prolonged length of stay in association to house-staff transitions of care.
SETTING: 10 University-affiliated U.S. Veterans Health Administration hospitals.
SYNOPSIS: 230,701 patient discharges (mean age, 65.6 years; 95.8% male sex; median length of stay, 3 days) were included. The transition group included patients admitted at any time prior to an end-of-rotation who were either discharged or deceased within 7 days of transition. All other discharges were considered controls.
The primary outcome was in-hospital mortality rate; secondary outcomes included 30-day and 90-day mortality and readmission rates. An absolute increase of 1.5% to 1.9% in a unadjusted in-hospitality risk was found. The 30-day and 90-day mortality odds ratios were 1.10 and 1.21, respectively. A possible stronger association was found among interns’ transitions in care and the in-hospital and after-discharge mortality post-ACGME 2011 duty hour regulations. The latter raises questions about the interns’ inexperience and their amount of shift-to-shift handoffs. An adjusted analysis of the readmission rates at 30-day and 90-day was not significantly different between transition vs. control patients.
BOTTOM LINE: Elevated in-hospital mortality was seen among patients admitted to the inpatient medicine service at the end-of-rotation resident transitions in care. The association was stronger after the duty-hour ACGME (2011) regulations.
CITATIONS: Denson JL, Jensen A, Saag HS, et al. Association between end-of-rotation resident transition in care and mortality among hospitalized patients. JAMA. 2016 Dec 6;316(21):2204-13.
Dr. Orjuela is assistant professor of neurology at the University of Colorado School of Medicine, Aurora
CLINICAL QUESTION: Are hospitalized patients experiencing an increased mortality risk at the end-rotation resident transition in care and is this association related to the Accreditation Council for Graduate Medical Education (ACGME) 2011 duty-hour regulations?
BACKGROUND: Prior studies of physicians’ transitions in care were associated with potential adverse patient events and outcomes. A higher mortality risk was suggested among patients with a complex hospital course or prolonged length of stay in association to house-staff transitions of care.
SETTING: 10 University-affiliated U.S. Veterans Health Administration hospitals.
SYNOPSIS: 230,701 patient discharges (mean age, 65.6 years; 95.8% male sex; median length of stay, 3 days) were included. The transition group included patients admitted at any time prior to an end-of-rotation who were either discharged or deceased within 7 days of transition. All other discharges were considered controls.
The primary outcome was in-hospital mortality rate; secondary outcomes included 30-day and 90-day mortality and readmission rates. An absolute increase of 1.5% to 1.9% in a unadjusted in-hospitality risk was found. The 30-day and 90-day mortality odds ratios were 1.10 and 1.21, respectively. A possible stronger association was found among interns’ transitions in care and the in-hospital and after-discharge mortality post-ACGME 2011 duty hour regulations. The latter raises questions about the interns’ inexperience and their amount of shift-to-shift handoffs. An adjusted analysis of the readmission rates at 30-day and 90-day was not significantly different between transition vs. control patients.
BOTTOM LINE: Elevated in-hospital mortality was seen among patients admitted to the inpatient medicine service at the end-of-rotation resident transitions in care. The association was stronger after the duty-hour ACGME (2011) regulations.
CITATIONS: Denson JL, Jensen A, Saag HS, et al. Association between end-of-rotation resident transition in care and mortality among hospitalized patients. JAMA. 2016 Dec 6;316(21):2204-13.
Dr. Orjuela is assistant professor of neurology at the University of Colorado School of Medicine, Aurora
VIDEO: Indomethacin slashes post-ERCP pancreatitis risk in primary sclerosing cholangitis
CHICAGO – Rectal indomethacin reduced by 90% the risk of post-procedural pancreatitis in patients with primary sclerosing cholangitis.
The anti-inflammatory has already been shown to reduce the risk of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a general population, Nikhil Thiruvengadam, MD, said at the annual Digestive Disease Week®. Now, his retrospective study of almost 5,000 patients has shown the drug’s benefit in patients with primary sclerosing cholangitis (PSC), who are at particularly high risk of pancreatitis after the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“A prior history of PEP and a difficult initial cannulation were significant risk factors for developing PEP,” he said. “Indomethacin significantly reduced this risk, and our findings suggest that future prospective trials studying pharmacological prophylaxis of PEP – including rectal indomethacin – should be powered to be able detect a difference in PSC patients, and they should be included in such studies.”
In 2016 Dr. Thiruvengadam and his colleagues showed that rectal indomethacin significantly reduced the risk of PEP by about 65% in a diverse group of patients, including those with malignant biliary obstruction (Gastroenterology. 2016;151:288–97). The new study used an expanded patient-cohort but focused on patients with PSC, as they require multiple ERCPs for diagnosis and stenting of strictures and cholangiocarcinoma screening and thus may be more affected by post-procedural pancreatitis.
The study comprised 4,764 patients who underwent ERCP at the University of Pennsylvania from 2007-2015; of these, 200 had PSC. Rectal indomethacin was routinely administered to patients beginning in June 2012. The primary outcome of the study was post-ERCP pancreatitis. The secondary outcome was the severity of post-ERCP pancreatitis.
PEP was about twice as common in the PSC group as in the overall cohort (6.5% vs. 3.8%). Moderate-severe PEP also was twice as common (4% vs. 2%).
Dr. Thiruvengadam broke down the cohort by indication for ERCP. These included PSC as well as liver transplant, choledocholithiasis, benign pancreatic disease, bile leaks, and ampullary adenoma. PSC patients had the highest risk of developing PEP – almost 3 times more than those without the disorder (OR 2.7).
Among PSC patients, age, gender, and total bilirubin were not associated with increased risk. A history of prior PEP increased the risk by 17 times, and a difficult initial cannulation that required a pre-cut sphincterotomy increased it by 15 times.
“Interestingly, dilation of a common bile duct stricture reduced the odds of developing PEP by 81%,” Dr. Thiruvengadam said.
He then examined the impact of rectal indomethacin on the study subjects. Overall, PEP developed in 5% of those who didn’t receive indomethacin and 2% of those who did. In the PSC group, PEP developed in 11% of those who didn’t get indomethacin and less than 1% of those who did.
Indomethacin was particularly effective at preventing moderate-severe PEP, Dr. Thiruvengadam noted. In the overall cohort, moderate-severe PEP developed in 3% of unexposed patients compared to 0.6% of those who received the drug. The difference was more profound in the PSC group: None of those treated with indomethacin developed moderate-severe PEP, which occurred in 9.3% of the unexposed group.
Generally, patients who have previously undergone a sphincterotomy are at lower risk for PEP, Dr. Thiruvengadam said, and this was reflected in the findings for the overall group: PEP developed in 3% of the untreated patients and 0.5% of the treated patients. Post-sphincterotomy patients with PSC, however, were still at an increased risk of PEP. Indomethacin significantly mitigated this – no patient who got the drug developed PEP, compared with 10.5% of those who didn’t get it.
A series of regression analyses confirmed the consistency of these findings. In an unadjusted model, rectal indomethacin reduced the risk of post-ERCP PEP by 91% in patients with PSC. A model that adjusted for common bile duct brushing, type of sedation, and common bile duct dilation found a 90% risk reduction. Another model that controlled for classic risk factors for PEP (age, gender, total bilirubin, history of PEP, pancreatic duct injection and cannulation, and pre-cut sphincterotomy) found a 94% risk reduction.
“We additionally performed a propensity score matched analysis to account for potential unmeasured differences between the two cohorts, and it also confirmed the results found and demonstrated that indomethacin significantly reduced the odds of developing PEP by 89%,” Dr. Thiruvengadam said.
He had no financial conflicts of interest to disclosures.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
[email protected]
On Twitter @Alz_gal
CHICAGO – Rectal indomethacin reduced by 90% the risk of post-procedural pancreatitis in patients with primary sclerosing cholangitis.
The anti-inflammatory has already been shown to reduce the risk of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a general population, Nikhil Thiruvengadam, MD, said at the annual Digestive Disease Week®. Now, his retrospective study of almost 5,000 patients has shown the drug’s benefit in patients with primary sclerosing cholangitis (PSC), who are at particularly high risk of pancreatitis after the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“A prior history of PEP and a difficult initial cannulation were significant risk factors for developing PEP,” he said. “Indomethacin significantly reduced this risk, and our findings suggest that future prospective trials studying pharmacological prophylaxis of PEP – including rectal indomethacin – should be powered to be able detect a difference in PSC patients, and they should be included in such studies.”
In 2016 Dr. Thiruvengadam and his colleagues showed that rectal indomethacin significantly reduced the risk of PEP by about 65% in a diverse group of patients, including those with malignant biliary obstruction (Gastroenterology. 2016;151:288–97). The new study used an expanded patient-cohort but focused on patients with PSC, as they require multiple ERCPs for diagnosis and stenting of strictures and cholangiocarcinoma screening and thus may be more affected by post-procedural pancreatitis.
The study comprised 4,764 patients who underwent ERCP at the University of Pennsylvania from 2007-2015; of these, 200 had PSC. Rectal indomethacin was routinely administered to patients beginning in June 2012. The primary outcome of the study was post-ERCP pancreatitis. The secondary outcome was the severity of post-ERCP pancreatitis.
PEP was about twice as common in the PSC group as in the overall cohort (6.5% vs. 3.8%). Moderate-severe PEP also was twice as common (4% vs. 2%).
Dr. Thiruvengadam broke down the cohort by indication for ERCP. These included PSC as well as liver transplant, choledocholithiasis, benign pancreatic disease, bile leaks, and ampullary adenoma. PSC patients had the highest risk of developing PEP – almost 3 times more than those without the disorder (OR 2.7).
Among PSC patients, age, gender, and total bilirubin were not associated with increased risk. A history of prior PEP increased the risk by 17 times, and a difficult initial cannulation that required a pre-cut sphincterotomy increased it by 15 times.
“Interestingly, dilation of a common bile duct stricture reduced the odds of developing PEP by 81%,” Dr. Thiruvengadam said.
He then examined the impact of rectal indomethacin on the study subjects. Overall, PEP developed in 5% of those who didn’t receive indomethacin and 2% of those who did. In the PSC group, PEP developed in 11% of those who didn’t get indomethacin and less than 1% of those who did.
Indomethacin was particularly effective at preventing moderate-severe PEP, Dr. Thiruvengadam noted. In the overall cohort, moderate-severe PEP developed in 3% of unexposed patients compared to 0.6% of those who received the drug. The difference was more profound in the PSC group: None of those treated with indomethacin developed moderate-severe PEP, which occurred in 9.3% of the unexposed group.
Generally, patients who have previously undergone a sphincterotomy are at lower risk for PEP, Dr. Thiruvengadam said, and this was reflected in the findings for the overall group: PEP developed in 3% of the untreated patients and 0.5% of the treated patients. Post-sphincterotomy patients with PSC, however, were still at an increased risk of PEP. Indomethacin significantly mitigated this – no patient who got the drug developed PEP, compared with 10.5% of those who didn’t get it.
A series of regression analyses confirmed the consistency of these findings. In an unadjusted model, rectal indomethacin reduced the risk of post-ERCP PEP by 91% in patients with PSC. A model that adjusted for common bile duct brushing, type of sedation, and common bile duct dilation found a 90% risk reduction. Another model that controlled for classic risk factors for PEP (age, gender, total bilirubin, history of PEP, pancreatic duct injection and cannulation, and pre-cut sphincterotomy) found a 94% risk reduction.
“We additionally performed a propensity score matched analysis to account for potential unmeasured differences between the two cohorts, and it also confirmed the results found and demonstrated that indomethacin significantly reduced the odds of developing PEP by 89%,” Dr. Thiruvengadam said.
He had no financial conflicts of interest to disclosures.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
[email protected]
On Twitter @Alz_gal
CHICAGO – Rectal indomethacin reduced by 90% the risk of post-procedural pancreatitis in patients with primary sclerosing cholangitis.
The anti-inflammatory has already been shown to reduce the risk of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a general population, Nikhil Thiruvengadam, MD, said at the annual Digestive Disease Week®. Now, his retrospective study of almost 5,000 patients has shown the drug’s benefit in patients with primary sclerosing cholangitis (PSC), who are at particularly high risk of pancreatitis after the procedure.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“A prior history of PEP and a difficult initial cannulation were significant risk factors for developing PEP,” he said. “Indomethacin significantly reduced this risk, and our findings suggest that future prospective trials studying pharmacological prophylaxis of PEP – including rectal indomethacin – should be powered to be able detect a difference in PSC patients, and they should be included in such studies.”
In 2016 Dr. Thiruvengadam and his colleagues showed that rectal indomethacin significantly reduced the risk of PEP by about 65% in a diverse group of patients, including those with malignant biliary obstruction (Gastroenterology. 2016;151:288–97). The new study used an expanded patient-cohort but focused on patients with PSC, as they require multiple ERCPs for diagnosis and stenting of strictures and cholangiocarcinoma screening and thus may be more affected by post-procedural pancreatitis.
The study comprised 4,764 patients who underwent ERCP at the University of Pennsylvania from 2007-2015; of these, 200 had PSC. Rectal indomethacin was routinely administered to patients beginning in June 2012. The primary outcome of the study was post-ERCP pancreatitis. The secondary outcome was the severity of post-ERCP pancreatitis.
PEP was about twice as common in the PSC group as in the overall cohort (6.5% vs. 3.8%). Moderate-severe PEP also was twice as common (4% vs. 2%).
Dr. Thiruvengadam broke down the cohort by indication for ERCP. These included PSC as well as liver transplant, choledocholithiasis, benign pancreatic disease, bile leaks, and ampullary adenoma. PSC patients had the highest risk of developing PEP – almost 3 times more than those without the disorder (OR 2.7).
Among PSC patients, age, gender, and total bilirubin were not associated with increased risk. A history of prior PEP increased the risk by 17 times, and a difficult initial cannulation that required a pre-cut sphincterotomy increased it by 15 times.
“Interestingly, dilation of a common bile duct stricture reduced the odds of developing PEP by 81%,” Dr. Thiruvengadam said.
He then examined the impact of rectal indomethacin on the study subjects. Overall, PEP developed in 5% of those who didn’t receive indomethacin and 2% of those who did. In the PSC group, PEP developed in 11% of those who didn’t get indomethacin and less than 1% of those who did.
Indomethacin was particularly effective at preventing moderate-severe PEP, Dr. Thiruvengadam noted. In the overall cohort, moderate-severe PEP developed in 3% of unexposed patients compared to 0.6% of those who received the drug. The difference was more profound in the PSC group: None of those treated with indomethacin developed moderate-severe PEP, which occurred in 9.3% of the unexposed group.
Generally, patients who have previously undergone a sphincterotomy are at lower risk for PEP, Dr. Thiruvengadam said, and this was reflected in the findings for the overall group: PEP developed in 3% of the untreated patients and 0.5% of the treated patients. Post-sphincterotomy patients with PSC, however, were still at an increased risk of PEP. Indomethacin significantly mitigated this – no patient who got the drug developed PEP, compared with 10.5% of those who didn’t get it.
A series of regression analyses confirmed the consistency of these findings. In an unadjusted model, rectal indomethacin reduced the risk of post-ERCP PEP by 91% in patients with PSC. A model that adjusted for common bile duct brushing, type of sedation, and common bile duct dilation found a 90% risk reduction. Another model that controlled for classic risk factors for PEP (age, gender, total bilirubin, history of PEP, pancreatic duct injection and cannulation, and pre-cut sphincterotomy) found a 94% risk reduction.
“We additionally performed a propensity score matched analysis to account for potential unmeasured differences between the two cohorts, and it also confirmed the results found and demonstrated that indomethacin significantly reduced the odds of developing PEP by 89%,” Dr. Thiruvengadam said.
He had no financial conflicts of interest to disclosures.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
[email protected]
On Twitter @Alz_gal
AT DDW
Key clinical point:
Major finding: The anti-inflammatory reduced the risk in these patients by 90%.
Data source: A retrospective study of 4,764 patients with PSC who underwent ERCP at a single institution, Disclosures: Dr. Thiruvengadam had no financial disclosures.
Vulnerable patients face higher risk of 30-day postpartum readmission
SAN DIEGO – Vulnerable patients experienced higher 30-day postpartum readmission rates, regardless of site of care, results from a large national analysis demonstrated.
“Although childbirth is the most common indication for inpatient admission in the United States – accounting for up to 4 million inpatient stays per year – national 30-day postpartum readmission rates, reasons for readmissions, and variation in readmission rates according to patient clinical and demographic characteristics on a national scale remain unknown,” Anju Ranjit, MD, said in an interview prior to the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Dr. Ranjit, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston, and her associates used multivariable logistic regression to compare differences in 30-day readmissions among 499,578 patients treated at hospitals serving a higher proportion of vulnerable patients (safety net hospitals) with the 30-day readmissions among 877,325 patients treated at hospitals serving a higher proportion of nonvulnerable patients (non–safety net hospitals). Models were adjusted for differences in patient demographics, comorbidities, pregnancy risk-status, type of deliveries, and hospital characteristics.
The researchers included 1,374,903 deliveries in the analysis, which were weighted to represent 3,113,047 deliveries nationwide. The national 30-day postpartum readmission rate was 1.4/100 deliveries. The top three reasons for readmission were wound infection (20.8%), infection (7.7%), and hypertension-related complications (6.2%).
Dr. Ranjit reported that in 2013, a total of 724,833 (53.3%) deliveries were to vulnerable patients and the remaining 652,070 (47.4%) to nonvulnerable patients. The rate of 30-day postpartum readmissions were higher among vulnerable patients, compared with their nonvulnerable counterparts (1.52% vs. 1.18%, respectively; adjusted odds ratio, 1.31; confidence interval, 1.26-1.37) and among patients who were treated at hospitals managing a higher proportion of vulnerable patients (1.51% vs. 1.27%; adjusted OR 1.19; CI, 1.12-1.27).*
“Higher readmission rates seen among vulnerable patients across institutions speak to the need to address disparities in perinatal care,” Dr. Ranjit said. “Quality improvement interventions targeted at safety net hospitals, where the majority of vulnerable patients seek care, could be helpful in reducing readmission rates among vulnerable populations.”
She acknowledged certain limitations of study, including the use of administrative data that is subject to coding error and that lacks clinical granularity.
“We were unable to control for patient’s race and region of residence due of lack of information,” she added. “Classification of hospitals into ‘safety net’ and ‘non–safety net’ hospitals was done – based on the proportion of vulnerable patients served, as identified in the national readmissions database – for the purpose of this study only.”
Dr. Ranjit reported having no financial disclosures.
* Correction, 05/08/17: An earlier version of this article incorrectly described the patient populations.
[email protected]
SAN DIEGO – Vulnerable patients experienced higher 30-day postpartum readmission rates, regardless of site of care, results from a large national analysis demonstrated.
“Although childbirth is the most common indication for inpatient admission in the United States – accounting for up to 4 million inpatient stays per year – national 30-day postpartum readmission rates, reasons for readmissions, and variation in readmission rates according to patient clinical and demographic characteristics on a national scale remain unknown,” Anju Ranjit, MD, said in an interview prior to the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Dr. Ranjit, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston, and her associates used multivariable logistic regression to compare differences in 30-day readmissions among 499,578 patients treated at hospitals serving a higher proportion of vulnerable patients (safety net hospitals) with the 30-day readmissions among 877,325 patients treated at hospitals serving a higher proportion of nonvulnerable patients (non–safety net hospitals). Models were adjusted for differences in patient demographics, comorbidities, pregnancy risk-status, type of deliveries, and hospital characteristics.
The researchers included 1,374,903 deliveries in the analysis, which were weighted to represent 3,113,047 deliveries nationwide. The national 30-day postpartum readmission rate was 1.4/100 deliveries. The top three reasons for readmission were wound infection (20.8%), infection (7.7%), and hypertension-related complications (6.2%).
Dr. Ranjit reported that in 2013, a total of 724,833 (53.3%) deliveries were to vulnerable patients and the remaining 652,070 (47.4%) to nonvulnerable patients. The rate of 30-day postpartum readmissions were higher among vulnerable patients, compared with their nonvulnerable counterparts (1.52% vs. 1.18%, respectively; adjusted odds ratio, 1.31; confidence interval, 1.26-1.37) and among patients who were treated at hospitals managing a higher proportion of vulnerable patients (1.51% vs. 1.27%; adjusted OR 1.19; CI, 1.12-1.27).*
“Higher readmission rates seen among vulnerable patients across institutions speak to the need to address disparities in perinatal care,” Dr. Ranjit said. “Quality improvement interventions targeted at safety net hospitals, where the majority of vulnerable patients seek care, could be helpful in reducing readmission rates among vulnerable populations.”
She acknowledged certain limitations of study, including the use of administrative data that is subject to coding error and that lacks clinical granularity.
“We were unable to control for patient’s race and region of residence due of lack of information,” she added. “Classification of hospitals into ‘safety net’ and ‘non–safety net’ hospitals was done – based on the proportion of vulnerable patients served, as identified in the national readmissions database – for the purpose of this study only.”
Dr. Ranjit reported having no financial disclosures.
* Correction, 05/08/17: An earlier version of this article incorrectly described the patient populations.
[email protected]
SAN DIEGO – Vulnerable patients experienced higher 30-day postpartum readmission rates, regardless of site of care, results from a large national analysis demonstrated.
“Although childbirth is the most common indication for inpatient admission in the United States – accounting for up to 4 million inpatient stays per year – national 30-day postpartum readmission rates, reasons for readmissions, and variation in readmission rates according to patient clinical and demographic characteristics on a national scale remain unknown,” Anju Ranjit, MD, said in an interview prior to the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Dr. Ranjit, a postdoctoral research fellow at Brigham and Women’s Hospital, Boston, and her associates used multivariable logistic regression to compare differences in 30-day readmissions among 499,578 patients treated at hospitals serving a higher proportion of vulnerable patients (safety net hospitals) with the 30-day readmissions among 877,325 patients treated at hospitals serving a higher proportion of nonvulnerable patients (non–safety net hospitals). Models were adjusted for differences in patient demographics, comorbidities, pregnancy risk-status, type of deliveries, and hospital characteristics.
The researchers included 1,374,903 deliveries in the analysis, which were weighted to represent 3,113,047 deliveries nationwide. The national 30-day postpartum readmission rate was 1.4/100 deliveries. The top three reasons for readmission were wound infection (20.8%), infection (7.7%), and hypertension-related complications (6.2%).
Dr. Ranjit reported that in 2013, a total of 724,833 (53.3%) deliveries were to vulnerable patients and the remaining 652,070 (47.4%) to nonvulnerable patients. The rate of 30-day postpartum readmissions were higher among vulnerable patients, compared with their nonvulnerable counterparts (1.52% vs. 1.18%, respectively; adjusted odds ratio, 1.31; confidence interval, 1.26-1.37) and among patients who were treated at hospitals managing a higher proportion of vulnerable patients (1.51% vs. 1.27%; adjusted OR 1.19; CI, 1.12-1.27).*
“Higher readmission rates seen among vulnerable patients across institutions speak to the need to address disparities in perinatal care,” Dr. Ranjit said. “Quality improvement interventions targeted at safety net hospitals, where the majority of vulnerable patients seek care, could be helpful in reducing readmission rates among vulnerable populations.”
She acknowledged certain limitations of study, including the use of administrative data that is subject to coding error and that lacks clinical granularity.
“We were unable to control for patient’s race and region of residence due of lack of information,” she added. “Classification of hospitals into ‘safety net’ and ‘non–safety net’ hospitals was done – based on the proportion of vulnerable patients served, as identified in the national readmissions database – for the purpose of this study only.”
Dr. Ranjit reported having no financial disclosures.
* Correction, 05/08/17: An earlier version of this article incorrectly described the patient populations.
[email protected]
AT ACOG 2017
Key clinical point:
Major finding: Vulnerable patients and safety net hospitals had higher rates and adjusted odds of readmission within 30 postdischarge days after delivery.
Data source: An analysis of the Nationwide Readmissions Database to identify deliveries during January 2013-October 2013.
Disclosures: Dr. Ranjit reported having no financial disclosures.
ACOG vows continued fight against rollback of women’s health protections
SAN DIEGO – Just days after the House passage of the GOP-backed American Health Care Act and signals that the Trump administration will revisit mandated coverage of contraception, leaders of the American Congress of Obstetricians and Gynecologists promised to continue fighting for coverage of women’s health services.
ACOG leaders said they have been working on advocacy in the Senate for months already, recognizing that a bill to repeal the Affordable Care Act could pass the House this year. The House-passed legislation, which still must pass the Senate, could be particularly detrimental to women’s health care, they said, because it includes a provision that would allow states to seek waivers for coverage of the essential health benefits package, which includes coverage of maternity care and contraceptives.
Before the ACA was enacted, only about 12% of insurance companies offered maternity care coverage and only three of four states required it, according to Thomas M. Gellhaus, MD, the outgoing ACOG president and an ob.gyn. in Iowa City. Because of the ACA requirements, all women now have that coverage. Additionally, the contraception coverage is what reduces maternal mortality, he said. “The fight will go on,” Dr. Gellhaus said. “We will not give up on this.”
ACOG has already been coordinating meetings between ob.gyns. and members of Congress and telephone calls before votes to reinforce the concerns with pending legislation and the impact it would have on women’s health care, Dr. Gellhaus said.
But this advocacy effort is not a partisan endeavor, said Mark DeFrancesco, MD, an ACOG past president and an ob.gyn. in Cheshire, Conn. “We’re going to stay out of politics,” he said. “You do that by making the only litmus test, ‘Is this good for women or not?’ ”
He added, “If you get out there with the ‘real facts’ ... it shouldn’t matter what your politics are or what your party is. It’s on us to explain things in such a way that we avoid rhetoric and we avoid the ideology.”
Dr. Brown, who encouraged ob.gyns. and their patients to reach out to their members of Congress in person in their home districts, said the message is simple: “This is what it means for your mother, this what it means for your sister, this is what it means for your wife, this is what it means for your daughters.”
[email protected]
On Twitter @maryellenny
SAN DIEGO – Just days after the House passage of the GOP-backed American Health Care Act and signals that the Trump administration will revisit mandated coverage of contraception, leaders of the American Congress of Obstetricians and Gynecologists promised to continue fighting for coverage of women’s health services.
ACOG leaders said they have been working on advocacy in the Senate for months already, recognizing that a bill to repeal the Affordable Care Act could pass the House this year. The House-passed legislation, which still must pass the Senate, could be particularly detrimental to women’s health care, they said, because it includes a provision that would allow states to seek waivers for coverage of the essential health benefits package, which includes coverage of maternity care and contraceptives.
Before the ACA was enacted, only about 12% of insurance companies offered maternity care coverage and only three of four states required it, according to Thomas M. Gellhaus, MD, the outgoing ACOG president and an ob.gyn. in Iowa City. Because of the ACA requirements, all women now have that coverage. Additionally, the contraception coverage is what reduces maternal mortality, he said. “The fight will go on,” Dr. Gellhaus said. “We will not give up on this.”
ACOG has already been coordinating meetings between ob.gyns. and members of Congress and telephone calls before votes to reinforce the concerns with pending legislation and the impact it would have on women’s health care, Dr. Gellhaus said.
But this advocacy effort is not a partisan endeavor, said Mark DeFrancesco, MD, an ACOG past president and an ob.gyn. in Cheshire, Conn. “We’re going to stay out of politics,” he said. “You do that by making the only litmus test, ‘Is this good for women or not?’ ”
He added, “If you get out there with the ‘real facts’ ... it shouldn’t matter what your politics are or what your party is. It’s on us to explain things in such a way that we avoid rhetoric and we avoid the ideology.”
Dr. Brown, who encouraged ob.gyns. and their patients to reach out to their members of Congress in person in their home districts, said the message is simple: “This is what it means for your mother, this what it means for your sister, this is what it means for your wife, this is what it means for your daughters.”
[email protected]
On Twitter @maryellenny
SAN DIEGO – Just days after the House passage of the GOP-backed American Health Care Act and signals that the Trump administration will revisit mandated coverage of contraception, leaders of the American Congress of Obstetricians and Gynecologists promised to continue fighting for coverage of women’s health services.
ACOG leaders said they have been working on advocacy in the Senate for months already, recognizing that a bill to repeal the Affordable Care Act could pass the House this year. The House-passed legislation, which still must pass the Senate, could be particularly detrimental to women’s health care, they said, because it includes a provision that would allow states to seek waivers for coverage of the essential health benefits package, which includes coverage of maternity care and contraceptives.
Before the ACA was enacted, only about 12% of insurance companies offered maternity care coverage and only three of four states required it, according to Thomas M. Gellhaus, MD, the outgoing ACOG president and an ob.gyn. in Iowa City. Because of the ACA requirements, all women now have that coverage. Additionally, the contraception coverage is what reduces maternal mortality, he said. “The fight will go on,” Dr. Gellhaus said. “We will not give up on this.”
ACOG has already been coordinating meetings between ob.gyns. and members of Congress and telephone calls before votes to reinforce the concerns with pending legislation and the impact it would have on women’s health care, Dr. Gellhaus said.
But this advocacy effort is not a partisan endeavor, said Mark DeFrancesco, MD, an ACOG past president and an ob.gyn. in Cheshire, Conn. “We’re going to stay out of politics,” he said. “You do that by making the only litmus test, ‘Is this good for women or not?’ ”
He added, “If you get out there with the ‘real facts’ ... it shouldn’t matter what your politics are or what your party is. It’s on us to explain things in such a way that we avoid rhetoric and we avoid the ideology.”
Dr. Brown, who encouraged ob.gyns. and their patients to reach out to their members of Congress in person in their home districts, said the message is simple: “This is what it means for your mother, this what it means for your sister, this is what it means for your wife, this is what it means for your daughters.”
[email protected]
On Twitter @maryellenny
AT ACOG 2017
Choice of lap vs. open SBO surgery still hinges on patient selection
PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.
In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.
The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.
During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.
“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.
The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.
When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.
“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”
The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”
These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”
In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.
Dr. Behman and Dr. Diebel reported having no financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.
In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.
The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.
During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.
“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.
The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.
When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.
“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”
The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”
These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”
In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.
Dr. Behman and Dr. Diebel reported having no financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.
PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.
In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.
The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.
During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.
“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.
The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.
When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.
“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”
The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”
These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”
In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.
Dr. Behman and Dr. Diebel reported having no financial disclosures
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: Laparoscopic surgery for SBO is associated with a greater risk of bowel intervention.
Major finding: The incidence of bowel intervention was 53.5% vs. 43.4% in laparoscopic and open procedures, respectively.
Data source: Review of 8,584 procedures for SBO in the Ministry of Health Ontario database performed from 2005 to 2014.
Disclosures: Dr. Behman and Dr. Diebel reported having no financial disclosures.
Sex-based differences in lung cancer screening intervals suggested
GENEVA – A lung-cancer screening CT interval of once-yearly for men and once every 3 years for women appears to be the optimum schedule for detecting most early-stage lung cancers while minimizing radiation exposure, results of a retrospective study suggest.
Among 96 patients (85 men and 11 women) with lung cancers detected on follow-up screening CT, the mean interval time between initial CT and diagnostic CT was significantly longer among women than among men, at 5.6 vs. 3.6 years (P = .02), reported Mi-Young Kim, MD, a radiologist at Asan Medical Center in Seoul, South Korea.
Men tended to have a higher stage at diagnosis, however. Stage I cancers were diagnosed in 82% of women, but only 49% of men. Tumor size was also larger among men at presentation at a mean of 29.5 mm vs. 15.5 mm, Dr. Kim and her colleagues found.
Current lung cancer screening guidelines vary somewhat, but most recommend annual screening for people aged 55-80 years who have a 30 pack-year or greater smoking history and are current smokers or have quit within the last 15 years.
Prior studies to see whether longer screening intervals were safe have yielded mixed results, possibly because of differences in clinical and radiologic presentation between men and women, Dr. Kim said.
To explore sex differences in lung cancer at the time of diagnosis, she and her colleagues retrospectively reviewed records for 46,766 patients who underwent screening at their center from January 2000 through February 2016, during which time, 282 patients were diagnosed with lung cancer. Of this group, 186 were diagnosed from the initial screening CT scan, and 96 – the cohort included in the study – were diagnosed from subsequent scans.
The authors found that the majority of men (72%) had solid nodules as the primary pathology. In contrast, ground-glass opacities were the most common nodular finding among women, occurring in 45% of the cases. The most common histology among men was adenocarcinoma (42%), followed by squamous-cell carcinoma (35%), small cell lung cancer (18%), and others (5%). All women presented with adenocarcinoma histology.
“Because ground-glass opacity nodule is the most common feature of lung cancer in women, and all cases are adenocarcinoma, the growth rate of cancers might be low,” Dr. Kim said in a statement.
Only 2 of the 11 women in the study were smokers, compared with 74 of the 85 men.
Looking at the operability of lung cancer according to screening intervals, the investigators found that 100% of tumors detected at 1 year in men were operable, compared with 94% of those detected at 2 years, and 55% for those detected at the 3-year interval. In contrast, among women, there were no tumors detected at 1 year, one operable tumor and no inoperable tumors at 2 years, and two operable and no inoperable tumors at 3 years. Beyond 3 years, however, the rate of inoperable tumors at the time of diagnosis was 32% in men and 25% in women.
“We included all patients screened for lung cancer in a 17-year period, but the number of women patients was low and further studies are needed to confirm the sex differences we found,” Dr. Kim acknowledged.
“Only when this is adjusted for – when we compare smokers of the same pack-year history – then we can look at whether women and men do have different rates of appearance of nodules,” he said.
“To me, this is a very interesting suggestion that indeed the biology of the growth of these nodules may be different in men and women, but only if we are sure that the main environmental factor is taken care of.”
The study funding source was not disclosed.
Dr. Kim and Dr. Boffetta reported no relevant disclosures.
GENEVA – A lung-cancer screening CT interval of once-yearly for men and once every 3 years for women appears to be the optimum schedule for detecting most early-stage lung cancers while minimizing radiation exposure, results of a retrospective study suggest.
Among 96 patients (85 men and 11 women) with lung cancers detected on follow-up screening CT, the mean interval time between initial CT and diagnostic CT was significantly longer among women than among men, at 5.6 vs. 3.6 years (P = .02), reported Mi-Young Kim, MD, a radiologist at Asan Medical Center in Seoul, South Korea.
Men tended to have a higher stage at diagnosis, however. Stage I cancers were diagnosed in 82% of women, but only 49% of men. Tumor size was also larger among men at presentation at a mean of 29.5 mm vs. 15.5 mm, Dr. Kim and her colleagues found.
Current lung cancer screening guidelines vary somewhat, but most recommend annual screening for people aged 55-80 years who have a 30 pack-year or greater smoking history and are current smokers or have quit within the last 15 years.
Prior studies to see whether longer screening intervals were safe have yielded mixed results, possibly because of differences in clinical and radiologic presentation between men and women, Dr. Kim said.
To explore sex differences in lung cancer at the time of diagnosis, she and her colleagues retrospectively reviewed records for 46,766 patients who underwent screening at their center from January 2000 through February 2016, during which time, 282 patients were diagnosed with lung cancer. Of this group, 186 were diagnosed from the initial screening CT scan, and 96 – the cohort included in the study – were diagnosed from subsequent scans.
The authors found that the majority of men (72%) had solid nodules as the primary pathology. In contrast, ground-glass opacities were the most common nodular finding among women, occurring in 45% of the cases. The most common histology among men was adenocarcinoma (42%), followed by squamous-cell carcinoma (35%), small cell lung cancer (18%), and others (5%). All women presented with adenocarcinoma histology.
“Because ground-glass opacity nodule is the most common feature of lung cancer in women, and all cases are adenocarcinoma, the growth rate of cancers might be low,” Dr. Kim said in a statement.
Only 2 of the 11 women in the study were smokers, compared with 74 of the 85 men.
Looking at the operability of lung cancer according to screening intervals, the investigators found that 100% of tumors detected at 1 year in men were operable, compared with 94% of those detected at 2 years, and 55% for those detected at the 3-year interval. In contrast, among women, there were no tumors detected at 1 year, one operable tumor and no inoperable tumors at 2 years, and two operable and no inoperable tumors at 3 years. Beyond 3 years, however, the rate of inoperable tumors at the time of diagnosis was 32% in men and 25% in women.
“We included all patients screened for lung cancer in a 17-year period, but the number of women patients was low and further studies are needed to confirm the sex differences we found,” Dr. Kim acknowledged.
“Only when this is adjusted for – when we compare smokers of the same pack-year history – then we can look at whether women and men do have different rates of appearance of nodules,” he said.
“To me, this is a very interesting suggestion that indeed the biology of the growth of these nodules may be different in men and women, but only if we are sure that the main environmental factor is taken care of.”
The study funding source was not disclosed.
Dr. Kim and Dr. Boffetta reported no relevant disclosures.
GENEVA – A lung-cancer screening CT interval of once-yearly for men and once every 3 years for women appears to be the optimum schedule for detecting most early-stage lung cancers while minimizing radiation exposure, results of a retrospective study suggest.
Among 96 patients (85 men and 11 women) with lung cancers detected on follow-up screening CT, the mean interval time between initial CT and diagnostic CT was significantly longer among women than among men, at 5.6 vs. 3.6 years (P = .02), reported Mi-Young Kim, MD, a radiologist at Asan Medical Center in Seoul, South Korea.
Men tended to have a higher stage at diagnosis, however. Stage I cancers were diagnosed in 82% of women, but only 49% of men. Tumor size was also larger among men at presentation at a mean of 29.5 mm vs. 15.5 mm, Dr. Kim and her colleagues found.
Current lung cancer screening guidelines vary somewhat, but most recommend annual screening for people aged 55-80 years who have a 30 pack-year or greater smoking history and are current smokers or have quit within the last 15 years.
Prior studies to see whether longer screening intervals were safe have yielded mixed results, possibly because of differences in clinical and radiologic presentation between men and women, Dr. Kim said.
To explore sex differences in lung cancer at the time of diagnosis, she and her colleagues retrospectively reviewed records for 46,766 patients who underwent screening at their center from January 2000 through February 2016, during which time, 282 patients were diagnosed with lung cancer. Of this group, 186 were diagnosed from the initial screening CT scan, and 96 – the cohort included in the study – were diagnosed from subsequent scans.
The authors found that the majority of men (72%) had solid nodules as the primary pathology. In contrast, ground-glass opacities were the most common nodular finding among women, occurring in 45% of the cases. The most common histology among men was adenocarcinoma (42%), followed by squamous-cell carcinoma (35%), small cell lung cancer (18%), and others (5%). All women presented with adenocarcinoma histology.
“Because ground-glass opacity nodule is the most common feature of lung cancer in women, and all cases are adenocarcinoma, the growth rate of cancers might be low,” Dr. Kim said in a statement.
Only 2 of the 11 women in the study were smokers, compared with 74 of the 85 men.
Looking at the operability of lung cancer according to screening intervals, the investigators found that 100% of tumors detected at 1 year in men were operable, compared with 94% of those detected at 2 years, and 55% for those detected at the 3-year interval. In contrast, among women, there were no tumors detected at 1 year, one operable tumor and no inoperable tumors at 2 years, and two operable and no inoperable tumors at 3 years. Beyond 3 years, however, the rate of inoperable tumors at the time of diagnosis was 32% in men and 25% in women.
“We included all patients screened for lung cancer in a 17-year period, but the number of women patients was low and further studies are needed to confirm the sex differences we found,” Dr. Kim acknowledged.
“Only when this is adjusted for – when we compare smokers of the same pack-year history – then we can look at whether women and men do have different rates of appearance of nodules,” he said.
“To me, this is a very interesting suggestion that indeed the biology of the growth of these nodules may be different in men and women, but only if we are sure that the main environmental factor is taken care of.”
The study funding source was not disclosed.
Dr. Kim and Dr. Boffetta reported no relevant disclosures.
FROM ELCC
Key clinical point:
Major finding: A repeated CT scan for lung cancer every year in men and every 3 years in women picked up most new, operable lesions.
Data source: Retrospective review of data on 96 patients with lung cancer diagnosed at a second or subsequent CT screening.
Disclosures: The study funding source was not disclosed. Dr. Kim and Dr. Boffetta reported no relevant disclosures.