Does minimally invasive surgery have a different impact on recurrence and overall survival in patients with pancreatic head versus body/tail cancer?

OBJECTIVE: This study sought to investigate the impact of minimally invasive surgery (MIS) on recurrence and overall survival between patients with pancreatic head versus body/tail cancers. METHODS: The risk factors associated with recurrence and long-term outcomes were analyzed according to tumor location and operative modality. RESULTS: A total of 288 and 87 patients underwent surgical resection for pancreatic head cancer and body/tail cancer, respectively. The perioperative outcomes and histopathologic results were comparable in open and MIS approach in both head and body/tail groups. There was no difference in local or systemic recurrence patterns and disease-free and overall survival rates according to primary tumor location and surgical modality. During subgroup analysis by stage; however, patients with stage III pancreatic head cancer in the MIS group had a decreased disease-free survival compared with those in the open surgery group (p = 0.020). On multivariate analysis, MIS was not a risk factor of total or local recurrences. CONCLUSIONS: Recurrence patterns and overall survival rates of patients did not differ according to tumor location and surgical approach. However, patients with stage III pancreatic head cancer in the MIS group showed inferior disease-free survival relative to patients who underwent open surgery.

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.

Residents perform better technically, have less stress and workload, and prefer robotic to laparoscopic technique during inanimate simulation.

INTRODUCTION: With the widespread adoption of minimally invasive surgery, there is a growing need for surgical residents to be trained by a procedure-specific curriculum. This study aimed to evaluate the technical performance and feedback of surgical residents undergoing the robotic and laparoscopic hepaticojejunostomy (HJ) and gastrojejunostomy (GJ) biotissue modules. METHODS: A total of 23 PGY-3 surgical residents participated in this study and performed the laparoscopic and robotic HJ and GJ drills, which were recorded and scored by two independent graders using the modified objective structured assessment of technical skills (OSATS). After completing each drill, all participants filled out the NASA Task Load Index (NASA-TLX), Borg Exertion Scale, and Edwards Arousal Rating Questionnaire. RESULTS: Twenty-two (95.7%) residents had already received fundamentals of laparoscopic surgery certification. Eighteen (78.3%) residents had robotic virtual simulation training and the median (range) number of robotic surgery console experience was 4 (0-30). In the HJ comparison of the six OSATS domains, the robotic system was superior in Gentleness (p = 0.031). In the GJ comparison, the robotic system was superior in Time and Motion (p < 0.001), Instrument Handling (p = 0.001), Flow of Operation (p = 0.002), Tissue Exposure (p = 0.013), and Summary (p < 0.001). Participants answered significantly higher demand scores for laparoscopy on all six facets of NASA-TLX for both HJ and GJ (p < 0.05). The Borg Level of Exertion was > 2 points higher for laparoscopic HJ and GJ (p < 0.001). Residents rated more Nervousness and Anxiety for laparoscopic compared to robotic (p < 0.05) HJ and GJ. Additionally, when asked to score preference for robotic and laparoscopic approach in terms of technique and ergonomics, residents scored robot as better (laparoscopy worse) for both HJ and GJ in both domains. CONCLUSIONS: The robotic surgical system provided a more favorable environment for trainees with less mental and physical burden for minimally invasive HJ and GJ curriculum.

Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.

Importance: Despite improvements in perioperative mortality, the incidence of postoperative surgical site infection (SSI) remains high after pancreatoduodenectomy. The effect of broad-spectrum antimicrobial surgical prophylaxis in reducing SSI is poorly understood. Objective: To define the effect of broad-spectrum perioperative antimicrobial prophylaxis on postoperative SSI incidence compared with standard care antibiotics. Design, Setting, and Participants: Pragmatic, open-label, multicenter, randomized phase 3 clinical trial at 26 hospitals across the US and Canada. Participants were enrolled between November 2017 and August 2021, with follow-up through December 2021. Adults undergoing open pancreatoduodenectomy for any indication were eligible. Individuals were excluded if they had allergies to study medications, active infections, chronic steroid use, significant kidney dysfunction, or were pregnant or breastfeeding. Participants were block randomized in a 1:1 ratio and stratified by the presence of a preoperative biliary stent. Participants, investigators, and statisticians analyzing trial data were unblinded to treatment assignment. Intervention: The intervention group received piperacillin-tazobactam (3.375 or 4 g intravenously) as perioperative antimicrobial prophylaxis, while the control group received cefoxitin (2 g intravenously; standard care). Main Outcomes and Measures: The primary outcome was development of postoperative SSI within 30 days. Secondary end points included 30-day mortality, development of clinically relevant postoperative pancreatic fistula, and sepsis. All data were collected as part of the American College of Surgeons National Surgical Quality Improvement Program. Results: The trial was terminated at an interim analysis on the basis of a predefined stopping rule. Of 778 participants (378 in the piperacillin-tazobactam group [median age, 66.8 y; 233 {61.6%} men] and 400 in the cefoxitin group [median age, 68.0 y; 223 {55.8%} men]), the percentage with SSI at 30 days was lower in the perioperative piperacillin-tazobactam vs cefoxitin group (19.8% vs 32.8%; absolute difference, -13.0% [95% CI, -19.1% to -6.9%]; P < .001). Participants treated with piperacillin-tazobactam, vs cefoxitin, had lower rates of postoperative sepsis (4.2% vs 7.5%; difference, -3.3% [95% CI, -6.6% to 0.0%]; P = .02) and clinically relevant postoperative pancreatic fistula (12.7% vs 19.0%; difference, -6.3% [95% CI, -11.4% to -1.2%]; P = .03). Mortality rates at 30 days were 1.3% (5/378) among participants treated with piperacillin-tazobactam and 2.5% (10/400) among those receiving cefoxitin (difference, -1.2% [95% CI, -3.1% to 0.7%]; P = .32). Conclusions and Relevance: In participants undergoing open pancreatoduodenectomy, use of piperacillin-tazobactam as perioperative prophylaxis reduced postoperative SSI, pancreatic fistula, and multiple downstream sequelae of SSI. The findings support the use of piperacillin-tazobactam as standard care for open pancreatoduodenectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT03269994.

Endovascular management of portal vein obstruction in hepatobiliary cancer patients.

BACKGROUND AND OBJECTIVES: The purpose of this article is to describe the procedural safety, technical success, and clinical success of endovascular management of portal and mesenteric venous obstruction in patients with hepatobiliary neoplasms. METHODS: Institutional Review Board (IRB)-approved HIPAA compliant retrospective review of 21 consecutive patients with hepatobiliary malignancies who underwent endovascular portal vein recanalization and stent placement between January 2012 and March 2020. Clinical diagnoses were pancreatic cancer (n = 19), colon cancer metastatic to the liver (n = 1), and cholangiocarcinoma (n = 1). Presenting signs and symptoms included: ascites, abdominal pain, abnormal liver function tests, diarrhea, and gastrointestinal bleeding. Stent patency and patient survival are presented with Kaplan-Meier method. RESULTS: The technical success rate was 100%. A transhepatic approach was used in 20 cases (95.2%); trans-splenic access in one. Primary stent patency was 95.2%, 84%, and 68% at 1, 3, and 6 months, respectively. All stent occlusions were caused by tumor progression. A total of 80% of patients reported symptomatic improvement. Patient survival at 10 months was 40%. The early death rate was 4.76%. There were no bleeding complications from the percutaneous tracts. CONCLUSION: Endovascular recanalization with stent placement is safe with high technical and clinical success.

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.

Cystic fibrosis F508del carriers and cancer risk: Results from the UK Biobank.

Cystic fibrosis (CF) carriers carrying one defective copy of a CFTR germline mutation are common in the general population. A recent study reported associations of CF carriers with risk for cancers of digestive organs and pancreatic cancer. In the current study, we assessed associations of CFTR F508del carriers with the risk for 54 types of cancers in the UK Biobank, a large population-based study. In Caucasians, compared to the carrier rate of 3.15% (12 357/392274) in noncancer subjects, the rate was significantly higher in cancer patients overall (2621/79619 = 3.29%), especially in patients with colorectal cancer (247/6667 = 3.70%), cancers of gallbladder and biliary tract (21/351 = 5.98%), thyroid cancer (30/665 = 4.51%) and unspecified non-Hodgkin's lymphoma (74/1805 = 4.10%), all P ≤ .05. In contrast, the carrier rate in patients with cancers of lung and bronchus was significantly lower (89/3463 = 2.57%), P = .05. The association of CFTR F508del carriers with these types of cancer remained significant after adjusting for respective cancer-specific risk factors. For pancreatic cancer, although a higher carrier rate (38/1004 = 3.78%) was found in patients with this cancer, the difference was not statistically significant (P = .26). This null association was unlikely due to lack of statistical power; the large sample size of our study had >80% power, at a significance level of .05, to detect an association of >1.5-fold increased risk. In conclusion, the identified associations of CFTR F508del carriers with multiple types of cancer may have potential biological and clinical implications if confirmed in independent study populations.

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.

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.

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.

Predicting Progression in Barrett's Esophagus: Development and Validation of the Barrett's Esophagus Assessment of Risk Score (BEAR Score).

OBJECTIVE: To develop and validate a scoring tool capable of accurately predicting which patients with Barrett's esophagus (BE) will progress to dysplasia and/or esophageal adenocarcinoma. BACKGROUND: Endoscopic therapies have emerged capable of eradicating BE with high efficacy and low complication rates, but which patients should receive treatment is still debated. Current knowledge of risk factors is insufficient to allow for the accurate prediction of which patients will progress to dysplasia or adenocarcinoma. METHODS: We retrospectively collected data from a cohort of BE patients over a 13-year period. A multivariable logistic regression model was constructed to predict progression. A simplified risk of progression (ROP) score was developed from weighted beta coefficients. Internal validation was performed using bootstrap analysis, and model discrimination was assessed using k-fold cross-validation. RESULTS: The cohort included 2591 BE patients of which 133 progressed to dysplasia/adenocarcinoma. Multivariable analysis with bootstrap internal validation resulted in 5 variables associated with an increased ROP (age ≥70 years, male sex, lack of proton-pump inhibitor use, segment greater than 3 cm, and history of esophageal candidiasis). Using this model, we developed a simple ROP score between 0 and 8. Receiver operating characteristic analysis showed a cutoff of 3 or higher to have a sensitivity and specificity of 70% and 79%, respectively. Patients with a score of 3 or higher had an odds ratio of 9.04 (95% confidence interval 6.06-13.46). The c-statistic obtained from 10-fold cross-validation was 0.76 (95% confidence interval 0.72-0.79), indicating good overall discrimination. CONCLUSIONS: Our data show the development and internal validation of the Barrett's Esophagus Assessment of Risk Score as capable of quantifying the likelihood of progression to dysplasia/adenocarcinoma. The Barrett's Esophagus Assessment of Risk Score can be used clinically to guide treatment decisions in nondysplastic BE patients.

Primary systemic therapy in resectable pancreatic ductal adenocarcinoma using mFOLFIRINOX: A pilot study.

BACKGROUND AND OBJECTIVES: Surgery followed by gemcitabine and/or a fluoropyrimidine is standard therapy for resectable PDAC. mFOLFIRINOX (oxaliplatin 85 mg/m2 , irinotecan 180 mg/m2 , leucovorin 400 mg/m2 Day 1, 5-FU 2400 mg/m2 × 48 h IV, peg-filgrastim 6 mg SQ day 3, every 14 days) has substantial activity in metastatic PDAC. We wished to determine the tolerability/efficacy of peri-operative mFOLFIRINOX in resectable PDAC. METHODS: Patients with resectable PDAC (ECOG PS 0/1) received four cycles of mFOLFIRINOX pre- and post-surgery. The primary endpoint was completion of preoperative chemotherapy plus resection. Secondary endpoints included completion of all therapy, R0 resection, treatment related toxicity, PFS, and OS. RESULTS: Twenty-one patients enrolled: median age 62 (47-78); 20/21 (95%) completed four cycles of preoperative mFOLFIRINOX; response by RECIST was 1 CR, 3 PR, 16 SD; 17/21 (81%) completed resection, 16/21 (76%) R0; 14/21 (66%) completed four cycles of postoperative mFOLFIRINOX. Grade 3 and 4 toxicity occurred in 23% and 14% patients pre-operatively, 26% and 6.0% post-operatively. Nine patients are alive with median follow-up of 27.7 (3.1-47.1) months. CONCLUSIONS: PST using mFOLFIRINOX in resectable PDAC is feasible and tolerable. R0 resection rate is high and survival promising, requiring longer follow-up and larger studies for definitive assessment.

The extent of vascular resection is associated with perioperative outcome in patients undergoing pancreaticoduodenectomy.

BACKGROUND: Few studies have examined the relation between extent of vascular resection and morbidity following pancreaticoduodenectomy (PD) with vein resection (PDVR). METHODS: Patients undergoing PD for malignancy were identified using the American College of Surgeons National Surgical Quality Improvement Project from 2006 to 2013. Current procedural terminology codes were used to characterize PDVR. RESULTS: 9235 patients underwent PD, 977 (10.6%) had PDVR - 640 with direct and 224 with graft repair. PDVR had longer operative times (456 ± 136 vs 374 ± 128 min, p < 0.05) and higher intraoperative transfusions (1.8 ± 3.4 vs 4.3 ± 4.9 units, p < 0.05) than PD alone. On adjusted multivariable regression, PDVR with either direct or graft repairs was associated with higher rates of overall morbidity (OR [odds ratio] 1.50 for direct, 1.74 for graft, p < 0.05), bleeding (OR 2.18 for direct, 3.26 for graft, p < 0.05), and DVT (OR 2.12 for direct, 2.62 for graft, p < 0.05) compared to PD alone. Graft repair was further associated with increased risk of reoperation (OR 1.59), septic shock (OR 2.77) and 30-day mortality (OR 2.72), all p < 0.05. DISCUSSION: The risk of significant morbidity and mortality for PDVR is associated with the extent of vascular resection, with graft repairs having increased morbidity and mortality rates.

Time to Initiation of Adjuvant Chemotherapy in Pancreas Cancer: A Multi-Institutional Experience.

BACKGROUND: Despite randomized trials addressing adjuvant therapy (AT) for pancreas cancer, the ideal time to initiate therapy remains undefined. Retrospective analyses of the ESPAC-3 trial demonstrated that time to initiation of AT did not impact overall survival (OS). Given the absence of confirmatory data outside of a clinical trial, we sought to determine if AT timing in routine clinical practice is associated with OS differences. METHODS: Perioperative data of pancreatectomies for ductal adenocarcinoma from five institutions (2005-2015) were assessed. Delay in AT was defined as initiation >12 weeks after surgery. Multivariate analysis was performed to identify predictors of mortality. RESULTS: Of 867 patients, 172 (19.8%) experienced omission of AT. Improved OS was observed in patients who received AT compared with patients who did not (24.8 vs. 19.1 months, p < 0.01). Information on time to initiation of AT was available in 488 patients, of whom 407 (83.4%) and 81 (16.6%) received chemotherapy ≤12 and >12 weeks after surgery, respectively. There were no differences in recurrence-free survival or OS (all p > 0.05) between the timely and delayed AT groups. After controlling for perioperative characteristics and tumor pathology, patients who initiated AT ≤ 12 or > 12 weeks after surgery had a 50% lower odds of mortality than patients who only underwent resection (p < 0.01). CONCLUSIONS: In a multi-institutional experience of resected pancreas cancer, delayed initiation of AT was not associated with poorer survival. Patients who do not receive AT within 12 weeks after surgery are still appropriate candidates for multimodal therapy and its associated survival benefit.

A Multi-institutional Comparison of Perioperative Outcomes of Robotic and Open Pancreaticoduodenectomy.

OBJECTIVES: Limited data exist comparing robotic and open approaches to pancreaticoduodenectomy (PD). We performed a multicenter comparison of perioperative outcomes of robotic PD (RPD) and open PD (OPD). METHODS: Perioperative data for patients who underwent postlearning curve PD at 8 centers (8/2011-1/2015) were assessed. Univariate analyses of clinicopathologic and treatment factors were performed, and multivariable models were constructed to determine associations of operative approach (RPD or OPD) with perioperative outcomes. RESULTS: Of the 1028 patients, 211 (20.5%) underwent RPD (4.7% conversions) and 817 (79.5%) underwent OPD. As compared with OPD, RPD patients had higher body mass index, rates of prior abdominal surgery, and softer pancreatic remnants, whereas OPD patients had a higher percentage of pancreatic ductal adenocarcinoma cases, and greater proportion of nondilated (<3 mm) pancreatic ducts. On multivariable analysis, as compared with OPD, RPD was associated with longer operative times [mean difference = 75.4 minutes, 95% confidence interval (CI) 17.5-133.3, P = 0.01], reduced blood loss (mean difference = -181 mL, 95% CI -355-(-7.7), P = 0.04) and reductions in major complications (odds ratio = 0.64, 95% CI 0.47-0.85, P = 0.003). No associations were demonstrated between operative approach and 90-day mortality, clinically relevant postoperative pancreatic fistula and wound infection, length of stay, or 90-day readmission. In the subset of 522 (51%) pancreatic ductal adenocarcinomas, operative approach was not a significant independent predictor of margin status or suboptimal lymphadenectomy (<12 lymph nodes harvested). CONCLUSIONS: Postlearning curve RPD can be performed with similar perioperative outcomes achieved with OPD. Further studies of cost, quality of life, and long-term oncologic outcomes are needed.

Adjuvant Therapy Improves Survival for T2N0 Gastric Cancer Patients with Sub-optimal Lymphadenectomy.

BACKGROUND: The benefit of adjuvant therapy following resection of early stage, node-negative gastric adenocarcinoma following a margin negative (R0) resection is unclear. METHODS: The National Cancer Data Base was used to identify patients with a T2N0 gastric adenocarcinoma (tumor invasion into the muscularis propria) who underwent R0 resection. Patients treated with neoadjuvant therapy and those for whom lymph node count was unavailable were excluded from the analysis. Kaplan-Meier and Cox regression were used to evaluate differences in and predictors of overall survival. RESULTS: A total of 1687 patients underwent R0 resection for T2N0 gastric adenocarcinoma between 2003-2011. Adjuvant chemotherapy treatment was administered to 7.1 and 14.1 % received adjuvant chemoradiation; 65.4 % had <15 lymph nodes examined. Multivariate Cox regression identified higher Charlson score, <15 lymph nodes examined, higher tumor grade, and tumor location in the cardia as factors associated with significantly decreased overall survival. With a median follow-up of 36 months, the 5-year overall survival was 71 % for patients with ≥15 lymph nodes examined and 53 % for those with <15 lymph nodes (p < 0.001). In patients who had <15 lymph nodes examined, there was an overall survival benefit for adjuvant chemoradiation (hazard ratio 0.71, p = 0.043). In patients with ≥15 lymph nodes examined, no survival benefit for adjuvant therapy was identified (p > 0.74). CONCLUSIONS: Adequate lymph node dissection and pathologic staging is critical in directing optimal treatment of patients with early gastric cancer. Understaging as a result of suboptimal lymphadenectomy may explain the perceived benefit of adjuvant chemoradiation after an R0 resection for T2N0 gastric cancer.

Management Controversies and Treatment Strategies for Borderline Resectable Pancreatic Cancer.

The management of borderline resectable cancer requires multi-disciplinary care including state-of-the-art radiographic imaging, combination treatment planning with medical oncology and radiation oncology, and technical surgical expertise combining gastrointestinal and vascular surgery.

Defining the Benefit of Adjuvant Therapy Following Resection for Intrahepatic Cholangiocarcinoma.

BACKGROUND: Intrahepatic cholangiocarcinoma (ICC) is rare but is increasing in incidence. While hepatectomy can be curative, the benefit of adjuvant therapy (AT) remains unclear. We utilized the National Cancer Data Base (NCDB) to isolate predictors of overall survival, describe the national pattern of AT administration, and identify characteristics of patients who experience a survival benefit from AT following resection for ICC. METHODS: Patients who were diagnosed with ICC between 1998 and 2006 and underwent surgical resection were identified through the NCDB. Kaplan-Meier and Cox regression analyses evaluated differences in overall survival between patients who received AT and those who did not. RESULTS: Overall, 638 patients who underwent surgery for ICC were identified. Multivariate Cox regression analysis identified positive lymph nodes, unexamined lymph nodes, positive margins, and lack of AT as predictors of decreased overall survival; 28.1 % of patients had positive margins while 20.1 % had positive nodes. These patients, as well as those who were younger and had fewer co-morbid conditions, were most likely to receive AT. After adjusting for other prognostic variables, patients were found to significantly benefit from AT if they had positive lymph nodes [chemotherapy: hazard ratio (HR) 0.54, p = 0.0365; chemoradiation: HR 0.50, p = 0.005] or positive margins (chemotherapy: HR 0.44, p = 0.0016; chemoradiation: HR 0.57, p = 0.0039). CONCLUSIONS: Positive lymph nodes and positive margins were associated with poor survival after resection for ICC. After controlling for other prognostic factors, AT was associated with significant survival benefits among patients with positive nodes or positive margins.

Reflux control is important in the management of Barrett's Esophagus: results from a retrospective 1,830 patient cohort.

BACKGROUND: It is unknown whether acid/reflux control prevents progression in Barrett's esophagus. In this study, we investigate whether medical or surgical control of reflux is associated with a decreased risk of progression to dysplasia/esophageal adenocarcinoma. METHODS: We retrospectively collected and analyzed data from a cohort of Barrett's esophagus patients participating in this single-center study comprised of all patients diagnosed with Barrett's esophagus at NorthShore University Health System hospitals and clinics over a 10-year period. Patients were followed in order to identify those progressing from Barrett's esophagus to low-grade dysplasia, high-grade dysplasia, and esophageal adenocarcinoma. We collected information from the patient's electronic medical records regarding demographic, endoscopic findings, histological findings, smoking/alcohol history, medication use including proton-pump inhibitors, and history of bariatric and antireflux surgery. Risk-adjusted modeling was performed using multivariable logistic regression. RESULTS: This study included 1,830 total Barrett's esophagus patients, 102 of which had their Barrett's esophagus progress to low-grade dysplasia, high-grade dysplasia, or esophageal adenocarcinoma (confirmed by biopsy) with an annual incidence rate of 1.1%. Mean follow-up period was 5.51 years (10,083 patient-years). Compared to the group that did not progress, the group that progressed was older (69.3 ± 13.7 vs. 63.9 ± 13.4 years. p < 0.001) and likely to be male (75 vs. 61%, p < 0.01). In the multivariable analysis, patients who had a history of antireflux surgery (n = 44) or proton-pump inhibitor use without surgery (n = 1,641) were found to progress at significantly lower rates than patients who did not have antireflux surgery or were not taking PPI's (OR 0.18, 95% CI 0.09-0.36). CONCLUSIONS: Reflux control was associated with decreased risk of progression to low-grade dysplasia, high-grade dysplasia, or esophageal adenocarcinoma. These results support the use of reflux control strategies such as proton-pump inhibitor therapy or surgery in patients with non-dysplastic Barrett's esophagus for the prevention of progression to dysplasia/adenocarcinoma.

Postoperative complications reduce adjuvant chemotherapy use in resectable pancreatic cancer.

OBJECTIVE: To assess the impact of postoperative complications on the receipt of adjuvant chemotherapy. BACKGROUND: Randomized trials have demonstrated that adjuvant chemotherapy is associated with improved long-term survival. However, pancreatic surgery is associated with significant morbidity and the degree to which complications limit subsequent treatment options is unknown. METHODS: Patients from the American College of Surgeons National Surgical Quality Improvement Program and the National Cancer Data Base who underwent pancreatic resection for cancer were linked (2006-2009). The associations between complications and adjuvant chemotherapy use or treatment delay (≥ 70 days from surgery) were assessed using multivariable regression methods. RESULTS: From 149 hospitals, 2047 patients underwent resection for stage I-III pancreatic adenocarcinoma of which 23.2% had at least 1 serious complication. Overall adjuvant chemotherapy receipt was 57.7%: 61.8% among patients not experiencing any complication and 43.6% among those who had a serious complication. Serious complications increased the likelihood of not receiving adjuvant therapy over twofold [odds ratio (OR) = 2.20, 95% confidence interval (CI): 1.73-2.80]. Specific complications associated with adjuvant chemotherapy omission were reintubation (OR = 7.79, 95% CI: 3.59-16.87), prolonged ventilation (OR = 5.92, 95% CI: 3.23-10.86), pneumonia (OR = 2.83, 95% CI: 1.63-4.90), sepsis/shock (OR = 2.76, 95% CI: 2.02-3.76), organ space/deep surgical site infection (OR = 2.19, 95% CI: 1.53-3.13), venous thromboembolism (OR = 1.92, 95% CI: 1.08-3.43), and urinary tract infection (OR = 1.61, 95% CI: 1.02-2.54). Serious complications also doubled the likelihood of delaying adjuvant treatment administration (OR = 2.08, 95% CI: 1.42-3.05). Sensitivity analysis in a younger, healthier patient cohort demonstrated similar associations. CONCLUSIONS: Postoperative complications are common following pancreatic surgery and are associated with adjuvant chemotherapy omission and treatment delays.