Disparities in Surgical Treatment of Resectable Pancreatic Adenocarcinoma at Minority Serving Hospitals.

INTRODUCTION: Minority serving hospitals (MSH) are those serving a disproportionally high number of minority patients. Previous research has demonstrated that treatment at MSH is associated with worse outcomes. We hypothesize that patients treated at MSH are less likely to undergo surgical resection of pancreatic adenocarcinoma compared to patients treated at non-MSH. METHODS: Patients with resectable pancreatic cancer were identified using the National Cancer Database. Institutions treating Black and Hispanic patients in the top decile were categorized as an MSH. Factors associated with the primary outcome of definitive surgical resection were evaluated using multivariable logistic regression. Univariate and multivariable survival analysis was performed. RESULTS: Of the 75,513 patients included in this study, 7.2% were treated at MSH. Patients treated at MSH were younger, more likely to be uninsured, and higher stage compared to those treated at non-MSH (P < 0.001). Patients treated at MSH underwent surgical resection at lower rates (MSH 40% versus non-MSH 44.5%, P < 0.001). On multivariable logistic regression, treatment at MSH was associated with decreased likelihood of undergoing definitive surgery (odds ratio 0.91, P = 0.006). Of those who underwent surgical resection, multivariable survival analysis revealed that treatment at an MSH was associated with increased morality (hazard ratio 1.12, P < 0.001). CONCLUSIONS: Patients with resectable pancreatic adenocarcinoma treated at MSH are less likely to undergo surgical resection compared to those treated at non-MSH. Targeted interventions are needed to address the unique barriers facing MSH facilities in providing care to patients with pancreatic adenocarcinoma.

Comparison of epidural infusion versus intrathecal morphine block as part of enhanced recovery after open pancreatoduodenectomy.

BACKGROUND AND OBJECTIVES: The accepted approach to pain management following open pancreatoduodenectomy (PD) remains controversial, with the most recent enhanced recovery after surgery (ERAS) protocols recommending epidural anesthesia (EA). Few studies have investigated intrathecal (IT) morphine, combined with transversus abdominis plane (TAP) blocks. We aim to compare the different approaches to pain management for open PD. METHODS: Patients who underwent open PD at our institution from 2020 to 2022 were included in the study. Patient characteristics, pain management, and postoperative outcomes between EA, IT morphine with TAP blocks, and TAP blocks only were compared using univariate analysis. RESULTS: Fifty patients were included in the study (58% male, median age 66 years [interquartile range, IQR: 58-73]). Most patients received IT morphine (N = 24, 48%) or EA (N = 18, 36%). The TAP block-only group required higher doses of postoperative narcotics while hospitalized (p = 0.004) and at discharge (p = 0.017). The IT morphine patients had a shorter median time to Foley removal (p = 0.007). Postoperative pain scores, non-opioid administration, postoperative bolus requirements, postoperative outcomes, and length of stay were similar between pain modalities. CONCLUSIONS: IT morphine and EA showed comparable efficacy with superior results compared to TAP blocks alone. Integration of IT morphine into PD ERAS protocols should be considered.

Extended postoperative thromboprophylaxis after pancreatic resection for pancreatic cancer is associated with decreased risk of venous thromboembolism in the minimally invasive approach.

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is associated with increased venous thromboembolism (VTE). We sought to compare rates of bleeding complications and VTE in patients receiving extended postoperative thromboprophylaxis (EPT) to those who did not, and identify risk factors for VTE after pancreatectomy for PDAC. METHODS: This is a retrospective review of pancreatectomies for PDAC. EPT was defined as 28 days of low molecular weight heparin. Multivariable analysis (MVA) was performed to identify independent risk factors of VTE. RESULTS: Of 269 patients included, 142 (52.8%) received EPT. Of those who received EPT, 7 (4.9%) suffered bleeding complications, compared to 6 (4.7%) of those who did not (p = 0.938). There was no significant difference in VTE rate at 90 days (2.8% vs. 2.4%, p = 0.728) or at 1 year (6.3% vs. 7.9%, p = 0.624). On MVA, risk factors for VTE included worse performance status, lower preoperative hematocrit, R1/R2 resection, and minimally invasive (MIS) approach. Among those who received EPT, there was no difference in VTE rate between MIS and open approach. CONCLUSIONS: EPT was not associated with a difference in VTE risk or bleeding complications. MIS approach was associated with a higher risk of VTE; however, this was significantly lower among those who received EPT.

Risk factors and outcomes in patients undergoing minimally invasive hepatectomy with unplanned conversion: a contemporary NSQIP analysis.

BACKGROUND: Minimally invasive techniques are growing for hepatectomies. Laparoscopic and robotic liver resections have been shown to differ in conversions. We hypothesize that robotic approach will have decreased conversion to open and complications despite being a newer technique than laparoscopy. METHODS: ACS NSQIP study using the targeted Liver PUF from 2014 to 2020. Patients grouped based on hepatectomy type and approach. Multivariable and propensity scored matching (PSM) was used to analyze the groups. RESULTS: Of 7767 patients who underwent hepatectomy, 6834 were laparoscopic and 933 were robotic. The rate of conversions was significantly lower in robotic vs laparoscopic (7.8% vs 14.7%; p < 0.001). Robotic hepatectomy was associated with decreased conversion for minor (6.2% vs 13.1%; p < 0.001), but not major, right, or left hepatectomy. Operative factors associated with conversion included Pringle (OR = 2.09 [95% CI 1.05-4.19]; p = 0.0369), and a laparoscopic approach (OR = 1.96 [95% CI 1.53-2.52]; p < 0.001). Undergoing conversion was associated with increases in bile leak (13.7% vs 4.9%; p < 0.001), readmission (11.5% vs 6.1%; p < 0.001), mortality (2.1% vs 0.6%; p < 0.001), length of stay (5 days vs 3 days; p < 0.001), and surgical (30.5% vs 10.1%; p < 0.001), wound (4.9% vs 1.5%; p < 0.001) and medical (17.5% vs 6.7%; p < 0.001) complications. CONCLUSION: Minimally invasive hepatectomy with conversion is associated with increased complications, and conversion is increased in the laparoscopic compared to a robotic approach.

Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Chemotherapy With and Without Sequential Cytoreductive Interventions for Patients with Oligometastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor Deoxyribose Nucleic Acid (ctDNA) Levels.

BACKGROUND: Metastatic adenocarcinomas of foregut origin are aggressive and have limited treatment options, poor quality of life, and a dismal prognosis. A subset of such patients with limited metastatic disease might have favorable outcomes with locoregional metastasis-directed therapies. This study investigates the role of sequential cytoreductive interventions in addition to the standard of care chemotherapy in patients with oligometastatic foregut adenocarcinoma. METHODS: This is a single-center, phase II, open-label randomized clinical trial. Eligible patients include adults with synchronous or metachronous oligometastatic (metastasis limited to two sites and amenable for curative/ablative treatment) adenocarcinoma of the foregut without progression after induction chemotherapy and having undetectable ctDNA. These patients will undergo induction chemotherapy and will then be randomized (1:1) to either sequential curative intervention followed by maintenance chemotherapy versus routine continued chemotherapy. The primary endpoint is progression-free survival (PFS), and a total of 48 patients will be enrolled to detect an improvement in the median PFS in the intervention arm with a hazard ratio (HR) of 0.5 with 80% power and a one-sided alpha of 0.1. Secondary endpoints include disease-free survival (DFS) in the intervention arm, overall survival (OS), ctDNA conversion rate pre/post-induction chemotherapy, ctDNA PFS, PFS2, adverse events, quality of life, and financial toxicity. DISCUSSION: This is the first randomized study that aims to prospectively evaluate the efficacy and safety of surgical/ablative interventions in patients with ctDNA-negative oligometastatic adenocarcinoma of foregut origin post-induction chemotherapy. The results from this study will likely develop pertinent, timely, and relevant knowledge in oncology.

Predictors of Conversion During Minimally Invasive Gastrectomy for Malignancy.

INTRODUCTION: Implementation of minimally invasive gastrectomy (MIG) for malignancy is increasing. However, risk factors for conversion to open surgery during laparoscopic and robotic gastrectomy are poorly understood. This study aimed to determine the risk factors for, and impact of, conversion during oncologic resection. METHODS: The National Cancer Database (NCDB) was used to identify patients with clinical stage I-III gastric cancer from 2010 to 2017. Chi-squared test and t-test were used to compare the robotic versus laparoscopic groups. Propensity score weighted multivariable logistic regression was used to evaluate factors associated with conversion to open surgery. RESULTS: Of 6990 patients identified, 5702 (81.6%) underwent a laparoscopic resection and 1288 (18.4%) underwent robotic-assisted resection. Conversion rates were 14.7% and 7.8% for laparoscopic and robotic gastrectomy, respectively. The robotic approach was associated with lower likelihood of conversion compared to laparoscopic approach (odds ratio [OR] = 0.470, P < 0.001). Other factors predictive of conversion included tumor size >5 cm compared to <2 cm (OR 1.714, P = 0.010), total gastrectomy compared to partial gastrectomy (OR 2.019, P < 0.001), antrum/pylorus (OR 2.345, P < 0.001), and body (OR 2.152, P < 0.001) tumors compared to cardia tumors. Compared to those treated with laparoscopic and robotic gastrectomy, patients who underwent conversion experienced significantly longer hospital length of stay and higher rates of positive surgical margins. CONCLUSIONS: Laparoscopic gastrectomy was associated with a higher conversion rate compared to robotic gastrectomy. Conversion to open surgery was associated with a significantly longer length of stay and higher rates of positive margins. Identification of risk factors for conversion can aid in appropriate modality selection.

Bile leak incidence, risk factors and associated outcomes in patients undergoing hepatectomy: a contemporary NSQIP propensity matched analysis.

BACKGROUND: Despite advances in surgical technique, bile leak remains a common complication following hepatectomy. We sought to identify incidence of, risk factors for, and outcomes associated with biliary leak. STUDY DESIGN: This is an ACS-NSQIP study. Distribution of bile leak stratified by surgical approach and hepatectomy type were identified. Univariate and multivariate factors associated with bile leak and outcomes were evaluated. RESULTS: Robotic hepatectomy was associated with less bile leak (5.4% vs. 11.4%; p < 0.001) compared to open. There were no significant differences in bile leak between robotic and laparoscopic hepatectomy (5.4% vs. 5.3%; p = 0.905, respectively). Operative factors risk factors for bile leak in patients undergoing robotic hepatectomy included right hepatectomy [OR 4.42 (95% CI 1.74-11.20); p = 0.002], conversion [OR 4.40 (95% CI 1.39-11.72); p = 0.010], pringle maneuver [OR 3.19 (95% CI 1.03-9.88); p = 0.044], and drain placement [OR 28.25 (95% CI 8.34-95.72); p < 0.001]. Bile leak was associated with increased reoperation (8.7% vs 1.7%, p < 0.001), 30-day readmission (26.6% vs 6.8%, p < 0.001), 30-day mortality (2% vs 0.9%, p < 0.001), and complications (67.2% vs 23.4%, p < 0.001) for patients undergoing MIS hepatectomy. CONCLUSION: While MIS confers less risk for bile leak than open hepatectomy, risk factors for bile leak in patients undergoing MIS hepatectomy were identified. Bile leaks were associated with multiple additional complications, and the robotic approach had an equal risk for bile leak than laparoscopic in this time period.

Heterogeneity in PD-L1 expression in malignant peritoneal mesothelioma with systemic or intraperitoneal chemotherapy.

Programmed death-ligand 1 (PD-L1) expression has been described in patients with malignant peritoneal mesothelioma (MPM), but treatment strategies utilising immune checkpoint inhibition are yet to be defined. Here, we examine levels of PD-L1 expression in MPM patients treated with systemic and/or intraperitoneal chemotherapy using tissue from patient tumour biopsies or resections at multiple time points. We found the mean PD-L1 expression was higher in those with a germline mutation and/or those with a higher somatic mutation burden. Moreover, PD-L1 expression was lower in patients who had received prior chemotherapy as compared to the treatment-naive cohort. Twenty patients who received chemotherapy, either systemic and/or peritoneal, between PD-L1 measurements showed marked heterogeneity. Six (30%) patients demonstrated upregulation of PD-L1, while eight (40%) demonstrated downregulation. Heterogeneity in PD-L1 expression in MPM before and after cytotoxic therapies may present an additional consideration when initiating immune checkpoint inhibition in this rare and challenging disease.

Cytoreductive Surgery for Selected Patients Whose Metastatic Gastric Cancer was Treated with Systemic Chemotherapy.

BACKGROUND: The authors hypothesized that cytoreductive surgery (CRS, comprising gastrectomy combined with metastasectomy) in addition to systemic chemotherapy (SC) is associated with a better survival than chemotherapy alone for patients with metastatic gastric adenocarcinoma (MGA). METHODS: Patients with MGA who received SC between 2004 and 2016 were identified using the National Cancer Database (NCDB). Nearest-neighbor 1:1 propensity score-matching was used to create comparable groups. Overall survival (OS) was compared between subgroups using Kaplan-Meier analyses. Immortal bias analysis was performed among those who survived longer than 90 days. RESULTS: The study identified 29,728 chemotherapy-treated patients, who were divided into the following four subgroups: no surgery (NS, n = 25,690), metastasectomy alone (n = 1170), gastrectomy alone (n = 2248), and CRS (n = 620) with median OS periods of 8.6, 10.9, 14.8, and 16.3 months, respectively (p < 0.001). Compared with the patients who underwent NS, the patients who had CRS were younger (58.9 ± 13.4 vs 62.0 ± 13.1 years), had a lower proportion of disease involving multiple sites (4.6% vs 19.1%), and were more likely to be clinically occult (cM0 stage: 59.2% vs 8.3%) (p < 0.001 for all). The median OS for the propensity-matched patients who underwent CRS (n = 615) was longer than for those with NS (16.4 vs 9.3 months; p < 0.001), including in those with clinical M1 stage (n = 210). In the Cox regression model using the matched data, the hazard ratio for CRS versus NS was 0.56 (95% confidence interval [CI], 0.49-0.63). In the immortal-matched cohort, the corresponding median OS was 17.0 versus 9.5 months (p < 0.001). CONCLUSIONS: In addition to SC, CRS may be associated with an OS benefit for a selected group of MGA patients meriting further prospective investigation.

Novel Application of Iterative Hyperthermic Intraperitoneal Chemotherapy for Unresectable Peritoneal Metastases from High-Grade Appendiceal Ex-Goblet Adenocarcinoma.

BACKGROUND: Peritoneal metastases (PMs) from appendiceal ex-goblet adenocarcinoma (AEGA) are associated with a poor prognosis. While cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) has been shown to prolong survival, the majority of patients are ineligible for complete cytoreduction. We describe a novel approach to the management of such patients with iterative HIPEC (IHIPEC). METHODS: Patients with signet ring/poorly differentiated AEGA with high Peritoneal Cancer Index (PCI) and extensive bowel involvement underwent IHIPEC with mitomycin C at 6-week intervals for a total of three cycles. Survival outcomes for these patients were compared with patients with high-grade appendiceal tumors matched for tumor burden who were treated with other conventional approaches, i.e. systemic chemotherapy only (SCO) or complete CRS + HIPEC. RESULTS: Between 2016 and 2019, seven AEGA patients with high PCI (median 32.5 [range 21-36]) underwent 18 IHIPEC cycles (median cycles per patient 3 [2-3]) in combination with systemic chemotherapy (median 2 lines [1-3], 12 cycles [10-28]). IHIPEC was delivered laparoscopically in 14/18 cases. Postoperatively, the median length of stay was 1 day (1-8 days), no procedure-related complications were reported, and five (28%) 90-day readmissions for bowel obstruction were documented. Median overall survival after IHIPEC was better compared with a matched group of patients (n = 16) receiving SCO (24.6 vs. 7.9 months; p = 0.005), and similar to those (n = 7) who underwent CRS + HIPEC (24.6 vs. 16.5 months; p = 0.62). CONCLUSIONS: IHIPEC in combination with systemic chemotherapy is tolerable, safe, and may be associated with encouraging survival outcomes compared with SCO in selected patients with high-grade, high-burden AEGA PM.

Robotic pancreaticoduodenectomy decreases the risk of clinically relevant post-operative pancreatic fistula: a propensity score matched NSQIP analysis.

BACKGROUND: A single-institution study demonstrated robotic pancreaticoduodenectomy (RPD) was protective against clinically-relevant postoperative pancreatic fistula (CR-POPF) compared to open pancreaticoduodenectomy (OPD). We sought to compare the national rate of CR-POPF by approach. METHODS: Procedure-targeted pancreatectomy Participant User Data File was queried from 2014 to 2017 for all patients undergoing pancreaticoduodenectomy. A modified fistula risk score was calculated and patients were stratified into risk categories. Multivariate logistic regression and propensity score matching was used. RESULTS: The rate of CR-POPF (15.6% vs. 11.9%; p = 0.026) was higher in OPD compared to RPD. On subgroup analysis, OPD had higher CR-POPF in high risk patients (32.9% vs. 19.4%; p = 0.007). On multivariable analysis OPD was a predictor of increased CR-POPF (Odds Ratio [OR] = 1.61 [1.15-2.25]; p = 0.005). Other operative factors associated with increased CR-POPF included soft pancreatic texture (OR = 2.65 [2.27-3.09]; p < 0.001) and concomitant visceral resection (OR = 1.41 [1.03-1.93]; p = 0.031). Increased duct size (reference <3 mm) was predictive of decreased CR-POPF: 3-6 mm (OR = 0.70 [0.61-0.81]; p < 0.001) and ≥6 mm (OR = 0.47 [0.37-0.60]; p < 0.001). Following propensity score matching, RPD continued to be protective against the occurrence of CR-POPF (OR = 1.54 [1.09-2.17]; p = 0.013). CONCLUSIONS: This is the largest multicenter study to evaluate the impact of RPD on POPF. It suggests that RPD can be protective against POPF, especially for high risk patients.

Benchmarking Perioperative Outcomes of Cytoreductive Surgery for Cancer: Implications for Quality Measurement.

BACKGROUND: Understanding variation and heterogeneity in practice patterns allows programs to develop effective strategies to improve patient outcomes. Cytoreductive surgery is a potentially highly morbid operation that could benefit from systematic assessments directed towards quality improvement. We describe the hospital-level variation and benchmarks for programs performing cytoreductive surgery. PATIENTS AND METHODS: Cytoreductive and tumor debulking operations with or without hyperthermic intraperitoneal chemotherapy performed for cancer between January 1, 2013 and June 30, 2018 were identified in the American College of Surgeons National Surgical Quality Improvement Program registry. Risk-adjusted hospital-level variation in 30-day death, serious morbidity, reoperation, readmission, and a composite of death or serious morbidity (DSM) were evaluated using hierarchical models. National Cancer Institute (NCI)-designated cancer center (NCI-CC) status was also explored. RESULTS: A total of 6203 operations across 589 hospitals were included, of which 56 were at NCI-CCs. Unadjusted rates of death, serious morbidity, reoperation, readmission, and DSM were 1.4%, 12.9%, 3.6%, 8.6%, and 13.4%, respectively. The coefficients of variation for hospital-level performance were 4.7%, 2.1%, 4.6%, 14.4%, and 1.0% for DSM, death, serious morbidity, unplanned reoperation, and unplanned readmissions, respectively. When compared with other hospitals, NCI-CCs had better risk-adjusted 30-day mortality (median odds ratio 0.984 versus 0.998, p < 0.001), but not for the other outcomes studied. CONCLUSIONS: Hospital-level variation was modestly detected using the usual measures of perioperative outcomes. Given the increasing interest in cytoreductive surgery, we demonstrate a clear opportunity to not only improve the quality of our care but to also better improve the way quality is measured for these patients.

Virtual Surgical Fellowship Recruitment During COVID-19 and Its Implications for Resident/Fellow Recruitment in the Future.

BACKGROUND: The COVID-19 pandemic has overlapped with the scheduled interview periods of over 20 surgical subspecialty fellowships, including the Complex General Surgical Oncology (CGSO) fellowships in the National Resident Matching Program and the Society of Surgical Oncology's Breast Surgical Oncology fellowships. We outline the successful implementation of and processes behind a virtual interview day for CGSO fellowship recruitment after the start of the pandemic. METHODS: The virtual CGSO fellowship interview process at the University of Chicago Medicine and NorthShore University Health System was outlined and implemented. Separate voluntary, anonymous online secure feedback surveys were email distributed to interview applicants and faculty interviewers after the interview day concluded. RESULTS: Sixteen of 20 interview applicants (80.0%) and 12 of 13 faculty interviewers (92.3%) completed their respective feedback surveys. Seventy-five percent (12/16) of applicants and all faculty respondents (12/12) stated the interview process was 'very seamless' or 'seamless'. Applicants and faculty highlighted decreased cost, time savings, and increased efficiency as some of the benefits to virtual interviewing. CONCLUSIONS: Current circumstances related to the COVID-19 pandemic require fellowship programs to adapt and conduct virtual interviews. Our report describes the successful implementation of a virtual interview process. This report describes the technical steps and pitfalls of organizing such an interview and provides insights into the experience of the interviewer and interviewee.

How to train and evaluate minimally invasive pancreas surgery.

Training for minimally invasive pancreas surgery is critical as an evolving body of literature supports its use with acceptable outcomes during training and improved short term outcomes following completion. Although case volume needed to achieve mastery remains unclear, improved outcomes for both laparoscopic and robotic pancreatectomy are demonstrated following a learning curve and inflection point. Therefore, dedicated training curricula for both laparoscopic and robotic pancreatectomy have been developed to mitigate this learning curve and improve outcomes.

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: Technical considerations and the learning curve.

Over the past decade, there has been a considerable increase in the utilization of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the management of patients with peritoneal metastases. This is due to improved safety and favorable oncologic outcomes, including curative potential. CRS/HIPEC has a steep learning curve and requires familiarity with peritonectomy procedures. This review will outline the technical aspects and learning curve of CRS/HIPEC.

Risk factors for complications in patients undergoing pancreaticoduodenectomy: A NSQIP analysis with propensity score matching.

BACKGROUND: Reports on the safety of minimally invasive pancreaticoduodenectomy compared to open pancreaticoduodenectomy (OPD) have demonstrated mixed results. One study comparing robotic pancreaticoduodenectomy (RPD) vs OPD demonstrated decreased complications associated with RPD. OBJECTIVES: To evaluate the morbidity of RPD vs OPD using a national data set. METHODS: This is a retrospective cohort study from 2014 to 2017. Factors associated with complications in patients undergoing pancreaticoduodenectomy were evaluated using multivariate logistic regression (MVA) and propensity score matching (PSM). RESULTS: Of 13 110 PDs performed over the study period, 12 612 (96.2%) were OPD and 498 (3.8%) were RPD. Patients who underwent RPD vs OPD were less likely to have any complications (46.8% vs 53.3%; P = .004), surgical complications (42.6% vs 48.6%; P = .008), wound complications (6.2% vs 9.1%; P = .029), clinically relevant postoperative pancreatic fistulas (11.9% vs 15.6%; P = .026), sepsis (6.2% vs 9.3%; P = .019), and pneumonia (1.6% vs 3.8%; P = .012). On MVA, OPD was associated with increased complications compared with RPD. On PSM analysis, OPD remained a significant predictor for any (OR, 1.29; 95% CI, 1.03-1.61; P = .029) and surgical (OR, 1.26; 95% CI, 1.00-1.58; P = .048) complications. CONCLUSIONS: This is the largest multicenter study to evaluate the impact of RPD on morbidity and suggests RPD is associated with decreased morbidity.

Prophylactic Cholecystectomy at Time of Surgery for Small Bowel Neuroendocrine Tumor Does Not Increase Postoperative Morbidity.

BACKGROUND: Prophylactic cholecystectomy at time of surgery for small bowel neuroendocrine tumor (SBNET) has been advocated, as these patients often go on to require somatostatin analogue therapy, which is known to increase risk of cholestasis and associated complications. Little is known regarding patterns of adoption of this practice or its associated morbidity. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database (2008-2014) was queried to identify patients who underwent SBNET resection. The risk differences of morbidity and mortality associated with performance of concurrent cholecystectomy were determined with multivariable adjustment for confounders. RESULTS: Among 1300 patients who underwent SBNET resection, 144 (11.1%) underwent concurrent cholecystectomy. Median age of patients undergoing cholecystectomy was 62 years [interquartile range (IQR) 52-69 years], and 75 were male. They more commonly had disseminated cancer (36.1 vs. 11.6%, p < 0.001) or SBNET located in duodenum (10.4 vs. 4.9%, p = 0.045) without difference in other baseline characteristics. Operative time was significantly longer in the cholecystectomy group (median 172 vs. 123 min, p < 0.001). Rate of postoperative morbidity was not significantly different between cholecystectomy and no-cholecystectomy groups (11.8 vs. 11.1%, p = 0.79). After adjustment for confounding, the risk difference of morbidity attributable to cholecystectomy was + 0.4% [95% confidence interval (CI) - 4.9 to + 5.6%]. Mortality within 30 days was not significantly different between cholecystectomy and no-cholecystectomy groups (1.4 vs. 0.6%, p = 0.29). CONCLUSIONS: Concurrent cholecystectomy at time of resection of SBNET is not associated with higher morbidity or mortality yet is performed in a minority of patients. Prospective study can identify which patients may derive benefit from this approach.

Identification of Patients for Adjuvant Therapy After Resection of Carcinoma of the Extrahepatic Bile Ducts: A Propensity Score-Matched Analysis.

BACKGROUND: Resectability rates for extrahepatic cholangiocarcinoma have increased over time, but long-term survival after resection alone with curative intent remains poor. Recent series suggest improved survival with adjuvant therapy. Patient subsets benefiting most from adjuvant therapy have not been clearly defined. METHODS: Patients with extrahepatic cholangiocarcinoma who underwent resection with curative intent and received adjuvant therapy (chemotherapy ± radiotherapy) or surgery alone (SA) were identified in the U.S. National Cancer Data Base (2004-2014). Cox regression identified covariates associated with overall survival (OS). Adjuvant therapy and SA cohorts were matched (1:1) by propensity scores based on the survival hazard in Cox modeling. Overall survival was compared by Kaplan-Meier estimates. RESULTS: Of 4872 patients, adjuvant chemotherapy was used frequently for 2416 (49.6%), often in conjunction with radiotherapy (RT) (n = 1555, 64.4%). Adjuvant chemotherapy with or without RT was used increasingly for cases with higher T classification [reference: T1-2; T3: 1.36; 95% confidence interval (CI), 1.19-1.55; T4: 1.77; 95% CI 1.38-2.26], nodal positivity [odds ratio (OR), 1.26; 95% CI 1.01-1.56], lymphovascular invasion (OR 1.21; 95% CI 1.01-1.46), or margin-positive resection (OR 1.85; 95% CI 1.61-2.12), and was associated with significant improvements in OS for each high-risk subset in the propensity score-matched cohort. Adjuvant therapy was associated with improved median OS for hilar tumors (40.0 vs 30.6 months; p = 0.025) but not distal tumors (33.0 vs 30.3 months; p = 0.123). Chemoradiotherapy was associated with superior outcomes compared with chemotherapy alone in the subset of margin-positive resection [hazard ratio (HR), 0.63; 95% CI 0.42-0.94]. CONCLUSIONS: Adjuvant multimodality therapy is associated with improved survival for patients with resected extrahepatic cholangiocarcinoma and high-risk features.