What Happens After Discharge? A 2+ Year Follow-Up After Laparoscopic Subtotal Fenestrating and Reconstituting Cholecystectomy.

Laparoscopic subtotal cholecystectomy (LSC) is utilized to prevent complications in the difficult cholecystectomy. Medium-term outcomes are poorly studied for fenestrating and reconstituting operative techniques. A single-institution retrospective review was undertaken of all LSCs. A telephone survey was used to identify complications addressed at other institutions. We performed subgroup analyses by operative approach and of patients requiring postoperative endoscopic intervention (ERC). 28 patients met inclusion criteria. The median follow-up was 32.7 months. There were no bile duct injuries or reoperations. 21% of patients required a postoperative ERC and 50% were discharged home with a drain. Bile leaks were found to be more prevalent in the fenestrating LSC group (38% vs 0%, P = .003). The case series suggested more severe recurrent biliary disease in patients undergoing reconstituting LSC. Laparoscopic subtotal cholecystectomy appears to have satisfactory medium-term outcomes. The reconstituting LSC group trends toward more severe recurrent disease which warrants further investigation.

National trends in utilization and safety of gastric bypass, sleeve gastrectomy and conversion surgery in patients with GERD.

BACKGROUND: While some studies have reported improvement in gastro-esophageal reflux disease (GERD) symptoms after sleeve gastrectomy (SG), others have reported higher incidence of de-novo GERD, worsening of prior GERD symptoms and erosive esophagitis post SG. Furthermore, GERD unresponsive to medical management is one of the most common indications for conversion of SG to Roux-en-Y gastric bypass (RYGB). Real-world data on safety of primary SG, primary RYGB and SG to RYGB conversion for obese patients with GERD would be helpful for informing surgeons and patient procedure selection. We sought to evaluate the trends in utilization and safety of primary RYGB and primary SG for patients with GERD requiring medications, and compare the peri-operative outcomes between primary RYGB and conversion surgery from SG to RYGB for GERD using the MBSAQIP database. METHODS: A comparative analysis of post-operative outcomes within 30 days was performed for primary RYGB and primary SG after 1:1 nearest neighbor propensity score matching for patient demographics and preoperative comorbidities using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) registry from 2015 to 2021. This was followed by comparison of peri-operative outcomes between conversion surgery from SG to RYGB for GERD and primary RYGB using MBSAQIP 2020-2021 data. RESULTS: Utilization of primary RYGB increased from 38% in 2015 to 45% in 2021, while primary SG decreased from 62% in 2015 to 55% in 2021 for bariatric patients with GERD. Post-operative outcomes including reoperation, reintervention, readmission, major complications, and death within 30 days were significantly higher for patients undergoing primary RYGB compared to primary SG. Increased readmissions and ED visits were seen with conversion surgery. However, there was no difference in rates of reoperation, reintervention, major complications, or death between primary RYGB and SG conversion to RYGB cohorts. CONCLUSIONS: This data suggests that a strategy of performing a primary SG and subsequent SG-RYGB conversion for those with recalcitrant GERD symptoms is not riskier than a primary RYGB. Thus, it may be reasonable to perform SG in patients who are well informed of the risk of worsening GERD requiring additional surgical interventions. However, the impact of such staged approach (SG followed by conversion to RYGB) on long-term outcomes remains unknown.

Weight loss and clinical outcomes following primary versus secondary Roux-en-Y gastric bypass: a multi-institutional experience.

BACKGROUND: Revisional bariatric surgeries are increasing for weight recurrence and return of co-morbidities. Herein, we compare weight loss and clinical outcomes following primary Roux-en-Y Gastric Bypass (P-RYGB), adjustable gastric banding to RYGB (B-RYGB), and sleeve gastrectomy to RYGB (S-RYGB) to determine if primary versus secondary RYGB offer comparable benefits. METHODS: Participating institutions' EMRs and MBSAQIP databases were used to identify adult patients who underwent P-/B-/S-RYGB from 2013 to 2019 with a minimum one-year follow-up. Weight loss and clinical outcomes were assessed at 30 days, 1 year, and 5 years. Our multivariable model controlled for year, institution, patient and procedure characteristics, and excess body weight (EBW). RESULTS: 768 patients underwent RYGB: P-RYGB n = 581 [75.7%]; B-RYGB n = 106 [13.7%]; S-RYGB n = 81 [10.5%]. The number of secondary RYGB procedures increased in recent years. The most common indications for B-RYGB and S-RYGB were weight recurrence/nonresponse (59.8%) and GERD (65.4%), respectively. Mean time from index operation to B-RYGB or S-RYGB was 8.9 and 3.9 years, respectively. After adjusting for EBW, 1 year %TWL (total weight loss) and %EWL (excess weight loss) were greater after P-RYGB (30.4%, 56.7%) versus B-RYGB (26.2%, 49.4%) or S-RYGB (15.6%, 37%). Overall comorbidity resolution was comparable. Secondary RYGB patients had a longer adjusted mean length of stay (OR 1.17, p = 0.071) and a higher risk of pre-discharge complications or 30-day reoperation. CONCLUSION: Primary RYGB offers superior short-term weight loss outcomes compared to secondary RYGB, with decreased risk of 30-day reoperation.

A surgeon's framework for the unplanned intraoperative consultation.

PURPOSE: Surgeons will likely be called to assist with or offer advice regarding an unanticipated intraoperative event or finding many times during their careers. Yet, there is no practical framework of how to respond to these consults nor is there any formal training in this area. The review of the limited literature and expert senior opinions can help explain the ethical components involved but does not address some of the practical aspects that the consulting surgeon may need to confront when responding to an unplanned intraoperative consultation. METHODS: We reviewed the existing surgical literature on intraoperative consultation across surgical disciplines and interpreted it in light of our own experiences and the advice of senior surgical colleagues. RESULTS: We present a framework for the minimum professional expectations of a surgeon responding to an intraoperative consultation. CONCLUSION: In this manuscript, we present a selected review of the available literature on the topic, establish some of the guiding ethical principles, and offer an actionable and detailed framework that can support trainees and practicing surgeons dealing with these increasingly common and stressful unplanned circumstances.

Increased incidence of marginal ulceration following conversion of sleeve gastrectomy to Roux-en-Y gastric bypass: a multi-institutional experience.

BACKGROUND: Marginal ulcer (MU) formation is a serious complication following Roux-en-Y Gastric Bypass (RYGB). Incidental data suggested a higher incidence of MU following conversion of Sleeve Gastrectomy to RYGB (S-RYGB). Herein, we evaluate the incidence of MU after primary versus secondary RYGB. METHODS: After IRB approval, each institution's electronic medical record and MBSAQIP database were queried to retrospectively identify adult patients who underwent primary RYGB (P-RYGB), Gastric Banding to RYGB (B-RYGB), or S-RYGB between 2014 and 2019, with minimum 1 year follow-up. Patient demographics, operative data, and post-operative outcomes were compared. Numeric variables were compared via two-sample t test, Wilcoxon test or Kruskal Wallis rank sum test. Two-sample proportion test or Fisher's exact test was employed for categorical and binary variables. p < 0.05 marked statistical significance. RESULTS: 748 patients underwent RYGB: P-RYGB n = 584 [78.1%]; B-RYGB n = 98 [13.1%]; S-RYGB n = 66 [8.8%]. Most patients were female (83.2%). Mean age was 45.7 years. Forty-six (n = 6.1%) patients developed MU, a median of 14 ± 32.2 months (range 0.5-82) post-operatively. Incidence of MU was significantly higher for patients undergoing S-RYGB (n = 9 [13.6%]), compared to P-RYGB (n = 34 [5.8%]) and B-RYGB (n = 3 [3.1%]) (p = 0.023). Median time (months) to MU was significantly shorter for patients who underwent S-RYGB (5 ± 6) compared to P-RYGB or B-RYGB (19 ± 37.5) (p = 0.035). Among those who developed MU, there was no significant difference in H. pylori status, NSAID, steroid, or tobacco use, irrespective of operation performed. CONCLUSION: In this multi-institutional cohort, patients who underwent S-RYGB had a significantly higher incidence of MU than those with P-RYGB or B-RYGB. Further research is needed to elucidate its pathophysiology and prevention strategies.

Socioeconomic disparities in the utilization of primary robotic hernia repair.

OBJECTIVE: This study aimed to examine socioeconomic disparities in the utilization of primary robotic hernia repair (RHR), utilizing statewide population-level data. It was funded by the SAGES Robotic Surgery Research Grant. METHODS AND PROCEDURES: The New York Statewide Planning and Research Cooperative System (SPARCS) administrative database was used to identify adult patients who underwent primary open, laparoscopic, and robotic hernia repair (inguinal, femoral, umbilical, ventral) from 2010 through 2016. Utilization trends were compared between the surgical approaches, assessing for difference in age, sex, race, insurance status, and socioeconomic status (as defined by median income for zip code). Multivariable regression models were used with statistical significance set at 0.05. RESULTS: A total of 280,064 patients underwent primary hernia repair: n = 216,892 (77.4%) open, n = 61,037 (21.8%) laparoscopic, and n = 2,135 (0.8%) robotic. After adjusting for confounding variables, senior age (OR 1.01, p = 0.002), male sex (OR 1.35, p < 0.001), and non-Hispanic race (OR 1.3-1.54, p < 0.001) were significantly associated with the use of robotic compared to open or laparoscopic surgery. Additionally, patients with commercial insurance were more likely to undergo RHR compared to those with Medicare (OR 1.32) or Medicaid (OR 1.54) (p < 0.0001). Income was significantly correlated with RHR such that every $10,000 increase in income would increase the odds of having RHR by 6% (OR 1.06, p < 0.0001). Academic facilities were also associated with a significantly higher likelihood of utilizing RHR (OR 1.88, p < 0.0001). CONCLUSION: There are significant socioeconomic disparities in the utilization of robotic compared to laparoscopic or open hernia repair. While the robotic approach is overall increasing in popularity, adoption of new technology should not be limited to specific socioeconomic cohorts of the population. Recognizing these disparities is a necessary first step in providing equal and consistent care.

Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: A Prospective Cohort Trial.

INTRODUCTION: Achieving satisfactory post-operative pain control for common elective general surgical procedures, while minimizing opioid utilization, remains challenging. Utilizing pre-operative educational strategies, as well as multimodal analgesia, we sought to reduce the post-operative opioid use in elective general surgery cases. METHODS: Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however, patients were not provided opioid prescriptions at discharge. Two weeks after discharge, patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge. RESULTS: A total of 129 patients were recruited for the study. Eighty-eight patients underwent inguinal hernia repair and 41 patients underwent cholecystectomy. Median post-operative morphine equivalents consumed in the Control cohort (n = 58); 46 (37.5-75) were significantly reduced when the OS protocol was enacted (n = 42); 15 (11-22.5) and further reduced to zero for every patient in the ZO cohort (n = 29) (P = 0.0001). There were no differences in patient-reported average pain scores after discharge (P = 0.08) or satisfaction levels with experience (P = 0.8302). CONCLUSIONS: Our study demonstrates that patient education and preoperative interventions can result in zero opioids prescribed after common general surgery procedures with equivalent patient satisfaction and pain scores.

Gender disparities among leadership in academic surgical publishing over the past decade.

BACKGROUND: Women account for 19 % of practicing surgeons in the United States, with representation decreasing with higher academic rank. Less is known about the proportion of women in editorial leadership positions at surgical journals. The objective of this study was to examine gender representation among editorial leadership at high-impact surgical journals. METHODS: The five journals with the highest impact factors in general, cardiothoracic, plastics, otolaryngology, orthopedics, urology, vascular, and neurosurgery were identified. Data were abstracted on the proportion of women editors-in-chief (EIC) and editorial board members between 2010 and 2020 to determine how these demographics changed over time. RESULTS: Multiple fields had no women EIC over the past decade (orthopedics, urology, cardiothoracic, neurosurgery). In all other fields, women were a minority of EIC. In 2020, women made up 7.9 % of EIC and 11.1 % of editorial boards in surgical journals. CONCLUSIONS: Women remain under-represented among leadership at high-impact surgical journals, with varying improvement over the past decade among different subspecialties.

Defining Global Benchmarks in Elective Secondary Bariatric Surgery Comprising Conversional, Revisional, and Reversal Procedures.

OBJECTIVE: To define "best possible" outcomes for secondary bariatric surgery (BS). BACKGROUND: Management of poor response and of long-term complications after BS is complex and under-investigated. Indications and types of reoperations vary widely and postoperative complication rates are higher compared to primary BS. METHODS: Out of 44,884 BS performed in 18 high-volume centers from 4 continents between 06/2013-05/2019, 5,349 (12%) secondary BS cases were identified. Twenty-one outcome benchmarks were established in low-risk patients, defined as the 75th percentile of the median outcome values of centers. Benchmark cases had no previous laparotomy, diabetes, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, thromboembolic events, BMI> 50 kg/m2 or age> 65 years. RESULTS: The benchmark cohort included 3143 cases, mainly females (85%), aged 43.8 ±â€Š10 years, 8.4 ±â€Š5.3 years after primary BS, with a BMI 35.2 ±â€Š7 kg/m2. Main indications were insufficient weight loss (43%) and gastro-esophageal reflux disease/dysphagia (25%). 90-days postoperatively, 14.6% of benchmark patients presented ≥1 complication, mortality was 0.06% (n = 2). Significantly higher morbidity was observed in non-benchmark cases (OR 1.37) and after conversional/reversal or revisional procedures with gastrointestinal suture/stapling (OR 1.84). Benchmark cutoffs for conversional BS were ≤4.5% re-intervention, ≤8.3% re-operation 90-days postoperatively. At 2-years (IQR 1-3) 15.6% of benchmark patients required a reoperation. CONCLUSION: Secondary BS is safe, although postoperative morbidity exceeds the established benchmarks for primary BS. The excess morbidity is due to an increased risk of gastrointestinal leakage and higher need for intensive care. The considerable rate of tertiary BS warrants expertise and future research to optimize the management of non-success after BS.

Comparative perioperative and 5-year outcomes of robotic and laparoscopic or open inguinal hernia repair: a study of 153,727 patients in the state of New York.

OBJECTIVE: This study aimed to examine the perioperative outcomes of robotic inguinal hernia repair as compared to the open and laparoscopic approaches utilizing large-scale population-level data. METHODS: This study was funded by the SAGES Robotic Surgery Research Grant (2019). The New York Statewide Planning and Research Cooperative System (SPARCS) administrative database was used to identify all adult patients undergoing initial open (O-IHR), laparoscopic (L-IHR), and robotic (R-IHR) inguinal hernia repair between 2010 and 2016. Perioperative outcome measures [complications, length of stay (LOS), 30-day emergency department (ED) visits, 30-day readmissions] and estimated 1/3/5-year recurrence incidences were compared. Propensity score (PS) analysis was used to estimate marginal differences between R-IHR and L-IHR or O-IHR, using a 1:1 matching algorithm. RESULTS: During the study period, a total of 153,727 patients underwent inguinal hernia repair (117,603 [76.5%] O-IHR, 35,565 [23.1%] L-IHR; 559 [0.36%] R-IHR) in New York state. Initial univariate analysis found R-IHR to have longer LOS (1.74 days vs. 0.66 O-IHR vs 0.19 L-IHR) and higher rates of overall complications (9.3% vs. 3.6% O-IHR vs 1.1% L-IHR), 30-day ED visits (11.6% vs. 6.1% O-IHR vs. 4.9% L-IHR), and 30-day readmissions (5.6% vs. 2.4% O-IHR vs. 1.2% L-IHR) (p < 0.0001). R-IHR was associated with higher recurrence compared to L-IHR. Following PS analysis, there were no differences in perioperative outcomes between R-IHR and L-IHR, and the difference in recurrence was found to be sensitive to possible unobserved confounding factors. R-IHR had significantly lower risk of complications (Risk difference - 0.09, 95% CI [- 0.13, - 0.056]; p < 0.0001) and shorter LOS (Ratio 0.53, 95% CI [0.45, 0.62]; p < 0.0001) compared to O-IHR. CONCLUSION: In adult patients, R-IHR may be associated with comparable to more favorable 30-day perioperative outcomes as compared with L-IHR and O-IHR, respectively.

Trends in the utilization and perioperative outcomes of primary robotic bariatric surgery from 2015 to 2018: a study of 46,764 patients from the MBSAQIP data registry.

BACKGROUND: Utilization of robotic surgery has increased over time. Outcomes in bariatric surgery have been variable. This study used the Metabolic and Bariatric Surgery Accreditation Quality and Improvement Program (MBSAQIP) dataset to compare nationwide trends in utilization and outcomes improvement for robotic and laparoscopic bariatric surgery over a four-year period. METHODS: We identified all adult patients who underwent robotic or laparoscopic primary sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) from 2015 to 2018. Those with previous bariatric/foregut surgery or open conversion were excluded. Trends in clinical outcomes of different surgery types over years were compared through multivariable regression models. Subgroup analysis was performed for patients in 2018, comparing outcomes among different surgery types. RESULTS: A total of 571,417 patients underwent bariatric surgery, of which 46,764 (8.2%) were performed robotically. Utilization of the robotic platform increased annually, from 6.7% in 2015 to 10.3% in 2018 (p < 0.0001). The majority of patients underwent SG (n = 33,891, 72.5%). Perioperative outcomes improved over time for both robotic and laparoscopic procedures. Improvement was more pronounced in the robotic cohort for extended length of stay (OR 0.76 vs 0.8, p < 0.0001) and operative time (OR 0.98 vs 0.99, p < 0.0001). In the 2018 subgroup, multivariable analysis found laparoscopic RYGB was associated with increased bleeding (OR 2.220, p = 0.0004), overall complications (OR 1.356, p = 0.0013), and extended LOS (OR 1.178, p < 0.0001) compared to robotic surgery. Laparoscopic SG was associated with decreased anastomotic/staple line leak (OR 0.718, p = 0.0321), 30-d readmission (OR 0.826, p = 0.0005), 30-d reintervention (OR 0.723, p = 0.0014), overall event (OR 0.862, p = 0.0009), and extended LOS (OR 0.950, p = 0.0113). Across the board, laparoscopic surgery was associated with decreased operative time (Adjusted Ratio = 0.704, p < 0.0001). CONCLUSION: Robotic utilization for bariatric surgery is increasing and outcomes continue to improve with time. There is a differential impact of the robotic approach on SG and RYGB, which requires further assessment.

Finding the Most Favorable Timing for Cholecystectomy after Percutaneous Cholecystostomy Tube Placement: An Analysis of Institutional and National Data.

BACKGROUND: Early cholecystectomy (E-CCY; 8 weeks or less) after percutaneous cholecystostomy tube (PCT) placement has been associated with increased postoperative complications, but this finding has not been validated at a national level and PCT-related complications and interventions (PCT-RCIs) were not evaluated. STUDY DESIGN: Adults with PCT for acute cholecystitis subsequently undergoing CCY were identified within the Nationwide Readmission Database (2010-2015) and our institution (2017-2019). Adjusted relative risks (aRRs) of postoperative complications were estimated using Poisson regression comparing E-CCY with delayed cholecystectomy (D-CCY; more than 8 weeks) within the nationwide cohort. Institutional PCT-RCIs, operative data, and postoperative outcomes were compared between E-CCY and D-CCY using chi-square and Kruskal-Wallis tests. RESULTS: Of 6,145 patients from the Nationwide Readmission Database, 32.9% were D-CCY. Risk-adjusted analysis identified no differences between E-CCY and D-CCY in complications (aRR 0.98; 95% CI, 0.89 to 1.07), mortality (aRR 0.88; 95% CI, 0.43 to 1.81), or 30-day readmissions (aRR 1.04; 95% CI, 0.85 to 1.27). Risk-adjusted analyses assessing the association of time to interval cholecystectomy (IC) with morbidity indicated an increased risk of surgical complications in the first month after PCT placement (aRR 1.17; 95% CI, 1.08 to 1.33). In the institutional cohort (E-CCY, n = 23; D-CCY, n = 45), there were no statistically significant differences found in estimated blood loss, length of stay, and postoperative complications. There were increased PCT-RCIs in the D-CCY group (26.9% E-CCY vs 69% D-CCY; p < 0.01) based on our unadjusted analysis. CONCLUSIONS: Increased operative complications when IC is performed within 1 month of PCT placement and increased PCT-RCIs when IC is performed 8 weeks after PCT placement suggest that the most favorable timing for IC is between 4 and 8 weeks after PCT placement.

Health disparity in access to bariatric surgery.

BACKGROUND: Sociodemographic disparities in terms of access to bariatric surgery are ongoing. OBJECTIVES: This study aimed to examine the trends for bariatric interventions based on patient characteristics from 2011 to 2018 in the state of New York. SETTING: Administrative statewide database. METHODS: This study used the New York Statewide Planning and Research Cooperative System database to identify all patients with obesity who underwent Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastrectomy (SG), and laparoscopic adjustable gastric banding (LAGB) between 2011 and 2018. The trends were studied for the types of bariatric procedures performed across different patient characteristics, including median household income as determined based on ZIP code. A multivariable logistic regression analysis was performed to compare the yearly trends. RESULTS: We identified 111,793 patients who underwent bariatric surgery. The number of bariatric procedures increased from 9304 in 2011 to 16,946 in 2018. RYGB was the most performed bariatric operation in 2011, but was replaced by SG from 2013 to 2018. Patients living in the highest decile median household income ZIP code areas had the highest increase in SG (odds ratio [OR], 1.51; 95% confidence interval [CI], 1.46-1.55; P < .0001) and the largest decrease in LAGB (OR, .53; 95% CI, .51-.56; P = .0007). CONCLUSIONS: The use of bariatric surgery increased significantly from 2011 to 2018. However, the disproportionately and substantially increased use of SG and the decreased use of LAGB in patients living in wealthier areas suggest that disparity in the use of bariatric interventions still exists. Public health efforts should be made to equalize access to bariatric surgery.

A Comprehensive Approach for the Prevention of Nausea and Vomiting Following Sleeve Gastrectomy: a Randomized Controlled Trial.

BACKGROUND: Postoperative nausea and vomiting (PONV) following sleeve gastrectomy (SG) is a common occurrence. The effect of specific interventions in PONV prevention within enhanced recovery pathways remains unclear. The aim of this study was to evaluate the impact of a comprehensive approach for the prevention of PONV on patient outcomes and hospital resource utilization. METHODS: A prospective randomized trial was conducted for patients undergoing SG. The intervention group received aprepitant and transdermal scopolamine preoperatively followed by ondansetron and dexamethasone intraoperatively, with total intravenous anesthesia. The control group received inhalational anesthetic and two intraoperative antiemetics without preoperative prophylaxis. The primary endpoint was a PONV-related delay in hospital discharge. RESULTS: Eighty-three patients completed the study (41 in the intervention and 42 in the control group). Eighty-nine percent of patients were discharged home on the first postoperative day. Four patients in the control group and none in the intervention group experienced a PONV-related delay in discharge (9.5% vs 0, p = 0.119). Intervention patients reported significantly lower PONV scores at all in-hospital time points examined (p = 0.0392 for verbal scores and p < 0.0001 for Rhodes Index) and significantly higher self-rated quality of recovery at 24 h (Quality of Recovery-15 instrument, p < 0.05). CONCLUSIONS: A multilevel approach to PONV leads to significantly lower severity of PONV and improved self-reported quality of recovery, compared with control. PONV-related readmissions, ED visits, and discharge delays were uncommon within the overall enhanced recovery cohort.

A step towards personalizing next line therapy for resected pancreatic and related cancer patients: A single institution's experience.

BACKGROUND: There is a lack of precision medicine in pancreatic ductal adenocarcinoma (PDA) and related cancers, and outcomes for patients with this diagnosis remain poor despite decades of research investigating this disease. Therefore, it is necessary to explore novel therapeutic options for these patients who may benefit from personalized therapies. OBJECTIVE: Molecular profiling of hepatopancreaticobiliary malignancies at our institution, including but not limited to PDA, was initiated to assess the feasibility of incorporating molecular profiling results into patient oncological therapy planning. METHODS: All eligible patients from Thomas Jefferson University (TJU) with hepatopancreaticobiliary tumors including PDA, who agreed to molecular testing profiling, were prospectively enrolled in a registry study from December 2014 to September 2017 and their tumor samples were tested to identify molecular markers that can be used to guide therapy options in the future. Next generation sequencing (NGS) and protein expression in tumor samples were tested at CLIA-certified laboratories. Prospective clinicopathologic data were extracted from medical records and compiled in a de-identified fashion. RESULTS: Seventy eight (78) patients were enrolled in the study, which included 65/78 patients with PDA (local and metastatic) and out of that subset, 52/65 patients had surgically resected PDA. Therapy recommendations were generated based on molecular and clinicopathologic data for all enrolled patients. NGS uncovered actionable alterations in 25/52 surgically resected PDAs (48%) which could be used to guide therapy options in the future. High expression of three proteins, TS (p = 0.005), ERCC1 (p = 0.001), and PD-1 (p = 0.04), was associated with reduced recurrence-free survival (RFS), while TP53 mutations were correlated with longer RFS (p = 0.01). CONCLUSIONS: The goal of this study was to implement a stepwise strategy to identify and profile resected PDAs at our institution. Consistent with previous studies, approximately half of patients with resected PDA harbor actionable mutations with possible targeted therapeutic implications. Ongoing studies will determine the clinical value of identifying these mutations in patients with resected PDA.

Cytoplasmic HuR Status Predicts Disease-free Survival in Resected Pancreatic Cancer: A Post-hoc Analysis From the International Phase III ESPAC-3 Clinical Trial.

OBJECTIVES: We tested cytoplasmic HuR (cHuR) as a predictive marker for response to chemotherapy by examining tumor samples from the international European Study Group of Pancreatic Cancer-3 trial, in which patients with resected pancreatic ductal adenocarcinoma (PDA) received either gemcitabine (GEM) or 5-fluorouracil (5-FU) adjuvant monotherapy. BACKGROUND: Previous studies have implicated the mRNA-binding protein, HuR (ELAVL1), as a predictive marker for PDA treatment response in the adjuvant setting. These studies were, however, based on small cohorts of patients outside of a clinical trial, or a clinical trial in which patients received multimodality therapy with concomitant radiation. METHODS: Tissue samples from 379 patients with PDA enrolled in the European Study Group of Pancreatic Cancer-3 trial were immunolabeled with an anti-HuR antibody and scored for cHuR expression. Patients were dichotomized into groups of high versus low cHuR expression. RESULTS: There was no association between cHuR expression and prognosis in the overall cohort [disease-free survival (DFS), P = 0.44; overall survival, P = 0.41). Median DFS for patients with high cHuR was significantly greater for patients treated with 5-FU compared to GEM [20.1 months, confidence interval (CI): 8.3-36.4 vs 10.9 months, CI: 7.5-14.2; P = 0.04]. Median DFS was similar between the treatment arms in patients with low cHuR (5-FU, 12.8 months, CI: 10.6-14.6 vs GEM, 12.9 months, CI: 11.2-15.4). CONCLUSIONS: Patients with high cHuR-expressing tumors may benefit from 5-FU-based adjuvant therapy as compared to GEM, whereas those patients with low cHuR appear to have no survival advantage with GEM compared with 5-FU. Further studies are needed to validate HuR as a biomarker in both future monotherapy and multiagent regimens.

A standardized comparison of peri-operative complications after minimally invasive esophagectomy: Ivor Lewis versus McKeown.

BACKGROUND: While our institutional approach to esophageal resection for cancer has traditionally favored a minimally invasive (MI) 3-hole, McKeown esophagectomy (MIE 3-hole) during the last five years several factors has determined a shift in our practice with an increasing number of minimally invasive Ivor Lewis (MIE IL) resections being performed. We compared peri-operative outcomes of the two procedures, hypothesizing that MIE IL would be less morbid in the peri-operative setting compared to MIE 3-hole. METHODS: Our institution's IRB-approved esophageal database was queried to identify all patients who underwent totally MI esophagectomy (MIE IL vs. MIE 3-hole) from June 2011 to May 2016. Patient demographics, preoperative and peri-operative data, as well as post-operative complications were compared between the two groups. Post-operative complications were analyzed using the Clavien-Dindo classification system. RESULTS: There were 110 patients who underwent totally MI esophagectomy (MIE IL n = 49 [45%], MIE 3-hole n = 61 [55%]). The majority of patients were men (n = 91, 83%) with a median age of 62.5 (range 31-83). Preoperative risk stratifiers such as ECOG score, ASA, and Charlson Comorbidity Index were not significantly different between groups. Anastomotic leak rate was 2.0% in the MIE IL group compared to 6.6% in the MIE 3-hole group (p = 0.379). The rate of serious (Clavien-Dindo 3, 4, or 5) post-operative complications was significantly less in the MIE IL group (34.7 vs. 59.0%, p = 0.013). Serious pulmonary complications were not significantly different (16.3 vs. 26.2%, p = 0.251) between the two groups. CONCLUSIONS: In this cohort, totally MIE IL showed significantly less severe peri-operative morbidity than MIE 3-hole, but similar rates of serious pulmonary complications and anastomotic leaks. These findings confirm the safety of minimally invasive Ivor Lewis esophagectomies for esophageal cancer when oncologically and clinically appropriate. Minimally invasive McKeown esophagectomy remains a satisfactory and appropriate option when clinically indicated.

Total parenteral nutrition in patients following pancreaticoduodenectomy: lessons from 1184 patients.

BACKGROUND: Total parenteral nutrition (TPN) has historically been used conservatively in the management of patients after pancreaticoduodenectomy (PD). Herein, we evaluate the indications for and outcomes associated with TPN use in a high-volume pancreatic surgery center. MATERIALS AND METHODS: We retrospectively queried our institution's pancreatic surgery database for patients who received TPN after PD from 2006 through 2015. RESULTS: Of 1184 patients who underwent PD, 232 (19.6%) received TPN perioperatively. The most common indications for TPN were delayed gastric emptying (DGE, n = 171, 73.7%), pancreatic fistula (n = 102, 44%), and generalized malnutrition (n = 25, 10.8%). The median day of TPN initiation was postoperative day 4 (range: -31 to 22), with a median usage of 9 days (range: 1-115). Forty-four (19%) patients received short-course TPN (≤3 days), primarily those diagnosed with isolated grade A DGE without associated complications (P = 0.0003). Multivariate analysis suggests the presence of deep surgical site infection (odds ratio: 3.09, [1.16-5.06], P = 0.018) or pancreatic fistula (odds ratio: 2.57, [1.03-6.41], P = 0.043) at the time of DGE presentation as predictive of long-term TPN requirement. Hyperglycemia (34.5%) was the most common complication resulting from TPN use, whereas central line-associated bloodstream infections (2.6%) were rare. Readmissions (35.3% TPN cohort; 15% historical institutional rate) were most commonly due to poor oral intake (26.8%). The 30-day mortality rate in the overall TPN cohort was 3.4% (0.8% historical institutional rate). CONCLUSIONS: TPN is a critical and safe adjunct for patients who develop PD-associated complications; however, it may be of limited utility for patients with isolated DGE.