INTRODUCTION:Achievement of pathologic complete response (pCR) following neoadjuvant chemotherapy (NAC) in patients with pancreatic ductal adenocarcinoma (PDAC) is associated with improved overall survival (OS). However, the role of adjuvant chemotherapy (AC) in this population remains unclear. This study aimed to evaluate whether AC confers additional OS benefit in patients with PDAC who achieve pCR. MATERIALS AND METHODS:Patients who received NAC, underwent surgical resection, and achieved pCR were identified from National Cancer Database (2012-2020). Patients were stratified based on receipt of AC and survival duration. Kaplan-Meier survival curves and multivariable Cox proportional hazards models were used to assess the association between AC and OS. RESULTS:Among 7973 patients, only 3.1% achieved pCR and had significantly improved OS compared to non-pCR patients (median 87.8 vs. 24.9 months, p < 0.001). Among pCR patients, only 18.6% received AC. AC was associated with significantly improved OS (median not reached vs. 80.3 months, p = 0.019) and remained independently associated with improved survival on multivariable analysis (HR 0.39, 95% CI 0.19-0.77; p = 0.007). AC was also associated with long-term survival (≥5 years) (unadjusted 28% vs. 14%, p = 0.005) and after adjustment (OR 2.54; 95% CI 1.23-5.37; p = 0.013). CONCLUSIONS:In PDAC patients achieving pCR following NAC and pancreatectomy, AC is associated with significantly improved OS and long-term survival, supporting the continued role of systemic therapy even in the setting of complete pathologic response.
Choledocholithiasis remains a common disease process to treat in modern medicine, but few are aware of its fascinating history. Starting with the preliminary understandings of ancient civilizations, significant strides in anatomic and pathologic characterization were made during the 16–18th centuries. In the latter half of the nineteenth century, the first cholecystectomy was performed, crossing an important surgical milestone that opened the door to further biliary intervention. Diagnostic advances were made and imaging techniques improved in the twentieth century, notably with Dr. George Berci’s groundbreaking advancement of cholangiography and performance of the first endoscopic common bile duct exploration. The development of endoscopic cholangiopancreatography (ERCP) in the 1970s and the introduction of laparoscopy brought the management of biliary disease into the modern era. In the future, we look towards improvements in safety, imaging techniques, instrumentation, and teaching strategies, among others, to further the field. In this article, we review the history of choledocholithiasis and the medical pioneers, importantly Dr. George Berci, who revolutionized the endoscopic and surgical treatment of this disease.
Walled-off pancreatic necrosis (WOPN) is a serious sequela following acute pancreatitis with significant associated morbidity and mortality. These guidelines provide best practice recommendations for the management of this complication. A systematic review was conducted, including a literature search from 1/1/2020 to 1/24/2025, addressing four key questions regarding the management of WOPN in adults. The findings were subsequently presented to a multidisciplinary panel of surgeons, gastroenterologists, and interventional radiologists, including those from both the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Americas Hepato-Pancreato-Biliary Association (AHPBA). The GRADE methodology was then used to develop evidence-based recommendations. All recommendations were based on very low certainty of evidence. A conditional recommendation was made for endoscopic management versus image-guided intervention. A conditional recommendation was made for image-guided intervention versus open surgery. A conditional recommendation was made for either minimally invasive surgery or image-guided intervention. A conditional recommendation was made for minimally invasive surgery versus endoscopic intervention. A conditional recommendation was made for either a pure endoscopic approach versus a step-up approach. These recommendations provide guidance for the approach to the management of WOPN according to the existing literature and expert input. The panel also highlighted evidence gaps to support future research for a stronger evidence base regarding the treatment of WOPN.
Background:Entrustable professional activities (EPAs) are widely used in competency-based medical education; however, most EPAs reflect skills expected later in training, limiting their ability to capture incremental progression among mid-level residents. This lack of granularity obscures meaningful development toward autonomy, undermines resident motivation, and delays identification of struggling learners. We describe a framework of nested EPAs in surgery-defined as smaller, discrete, professional tasks embedded within core EPAs-to address gaps in assessing mid-level trainee progression. This model can be adapted across medical specialties facing similar assessment limitations. Objective:To describe the development of nested EPAs using surgery as a reproducible model for other specialties. Methods:In 2024, we created descriptions for nested EPAs using a systematic process. We developed 160 narratives across 10 nested EPAs, organized into 4 performance domains: anatomy, surgical technique, potential errors, and operative steps, each with 4 levels of increasing autonomy (10×4×4). Second, we performed a Delphi consensus study to finalize the nested EPAs and associated narratives (80% agreement for consensus). The Delphi panel included 15 surgical experts (5 women and 10 men) from 8 surgical subspecialties, affiliated with 1 general surgery residency program. The focus was on intraoperative nested EPAs. Results:In the first round, 136 of 160 items (85%) reached consensus, with 17 updated based on feedback and included in the second round along with 24 items that initially did not meet consensus. All 41 revised items (100%) achieved consensus in the second round. Conclusions:We demonstrated a model for developing nested EPAs.
Background Safety-net hospitals (SNHs) provide a substantial segment of the U.S. population with complex health needs, yet the breadth of oncologic services available at SNHs remains unclear.Methods A survey on cancer-care delivery was distributed to oncology providers at stand-alone California SNHs. The survey queried feasibility, access, and wait times for screening exams, diagnostic tests, procedures, and specialist services for comprehensive cancer care.Results Of 15 SNHs queried, nine (60%) responded. Access to full-time surgical specialists varied considerably: 33% lacked breast surgeons and urologists, 44% lacked surgical oncologists/hepatobiliary and colorectal surgeons, 56% lacked thoracic surgeons, 67% lacked endocrine surgeons, and 89% lacked orthopedic oncologists. Most hospitals (78%) employ general surgeons to perform cancer operations. Specific procedures are performed with the following frequency: right hemicolectomy/LAR/APR 89%, gastrectomy 78%, pulmonary lobectomy 78%, pancreaticoduodenectomy 67%, melanoma surgery 67%, major hepatectomy 56%. Robotic surgery is available at two-thirds of SNHs. One hospital offered CRS/HIPEC, and no respondent site provided regional intraoperative chemotherapy techniques.Conclusions Like the United States as a whole, much cancer surgery in respondent California SNHs is performed by general surgeons. Significant gaps in subspecialty and advanced therapies persist, potentially requiring patients to travel long distances to tertiary centers and limiting access to comprehensive cancer care.
BackgroundIntraoperative identification of Rouvière's sulcus is a proposed strategy to prevent bile duct injuries. Since it marks the plane at which the extra-hepatic ducts lie, limiting surgical dissection ventral to Rouvière's sulcus should protect the ducts from injury. This is an important adjunct when the critical view of safety cannot be achieved during difficult cholecystectomies.MethodsThis was an observational study of all consecutive elective laparoscopic cholecystectomies between January 1, 2017 and May 30, 2024. Intraoperatively, Rouvière's sulcus was identified by surgeons, with correlation by an independent observer. The relationship between the sulcus and the right hepatic pedicle was confirmed by laparoscopic ultrasound. Comparisons were made using SPSS.ResultsOver 7 years, 356 laparoscopic cholecystectomies were performed, and Rouvieré's sulcus could be identified in 296 (83.2%) patients. When a well-defined sulcus was present, it correlated reliably to the right portal triad in all cases. However, the reliability of this relationship significantly reduced in the absence of a well-defined sulcus (100% vs 5%; P < 0.0001).ConclusionsWhen present, Rouvieré's sulcus is a valuable asset to surgeons, who can use it as a landmark for safe dissection planes during cholecystectomies. When a well-defined sulcus is absent, surgeons should employ alternative means of bile duct protection, such as indocyanine green or operative cholangiography.
Objective We aimed to understand general surgery applicants’ experiences with and attitudes toward preference signaling. Design Qualitative analysis of de-identified transcripts from semi-structured interviews of general surgery residency applicants was performed. Setting A general surgery residency program at an academic hospital in the United States. Participants All applicants to one general surgery residency program in the 2024 to 2025 recruitment cycle were invited to participate. Twenty-seven applicants participated in semi-structured interviews (59% female, 63% MD graduates, 11% DO graduates, 26% international medical school graduates). Results While applicants decided where to signal differently, applicants noted that they signaled across a range of program competitiveness and made strategic choices based on interest versus likelihood of matching. While applicants highlighted the importance of a good advisor, they noted that disagreements were common between advisors regarding signaling strategies. Applicants additionally noted a disparity in advising for IMG and DO applicants, as their schools often did not have surgery-specific advisors or a track record of matching into surgical specialties. Applicants focused on several signaling pitfalls, including difficulty judging their competitiveness and determining where they would "fit" before their interviews. While applicants did not expect to receive interview offers from non-signaled programs, they found these interviews could go 2 ways: either non-signaled programs were a good fit, or they experienced quasi-adversarial interactions about their potential lack of interest. With respect to future changes, applicants wanted more transparency regarding each program’s screening process and felt that signal number changes should be data-driven to ensure applicants receive enough interviews to match. Conclusions Applicants had varied experiences with signaling, reporting different allocation strategies and guidance from advisors. Applicants highlighted a need for transparency regarding how applicants should signal and how programs interpret signals. This transparency can break down the hidden curriculum of signaling, improving applicant trust in the recruitment process.
BACKGROUND:The survival benefit of neoadjuvant chemotherapy (NAC) in early-stage pancreatic ductal adenocarcinoma (PDAC) remains uncertain. Although retrospective studies often suggest improved outcomes, these findings may be confounded by immortal time bias (ITB), the interval between diagnosis and treatment during which patients must survive to receive therapy, potentially inflating survival estimates. This study applied multiple bias-adjusted analytic methods to re-evaluate the association between NAC and overall survival in early-stage PDAC. METHODS:Using the National Cancer Database (2012-2017), we identified adults with resectable clinical T1 and T2 PDAC who underwent pancreatectomy. Overall survival was compared between multiagent NAC and upfront surgery by using Kaplan-Meier and multivariable Cox models. We used three statistical approaches to adjust for immortal time bias: 1) a 9-month landmark analysis; 2) a time-varying Cox regression model; and 3) a propensity-matched time-varying Cox model. RESULTS:Among 13,466 patients, 15.8% received NAC. Before bias adjustment, NAC was associated with longer median survival (33.4 vs. 25.7 months; HR 0.78, p < 0.001). However, after correcting for immortal time bias, this apparent survival advantage disappeared: landmark analysis (HR 0.94, p = 0.072), time-varying model (HR 1.06, p = 0.2), and matched cohort (HR 0.94, p = 0.2). CONCLUSIONS:This study shows that ITB significantly influences survival estimates in retrospective analyses of NAC for early-stage resectable PDAC. When appropriately adjusted, NAC was not associated with a survival advantage compared to upfront surgery. These findings underscore the need for methodological rigor in retrospective studies and caution against overinterpreting unadjusted survival advantages.
To establish international benchmark values for relevant outcome parameters in robotic Whipple. For safe adoption of surgical innovation, robust quality control is essential. Benchmarking is a validated tool for assessing surgical performance. Recent international consensus identified establishing benchmark values for robotic Whipple as top priority. We analyzed consecutive patients undergoing robotic Whipple between 2020-2023 with a minimum one-year follow-up. Reference centers were required to perform ≥15 cases/year, be scientifically active in the field, and maintain a prospective database. Benchmark criteria included benign or resectable malignant disease without neoadjuvant therapy, arterial resection, major co-morbidities, or significant previous abdominal surgery. Benchmarks were established for 13 outcome parameters. The benchmark cohort comprised 418 patients from 12 centers across four continents. Benchmark values were: conversion rate ≤4.3%, transfusion rate ≤2.1%, 6-month mortality ≤2.2%, major complications ≤23.2%, and CCI® ≤20.9. Clinically relevant pancreatic fistula (grade B/C) and hemorrhage (grade B/C) rates were ≤23.6% and ≤12.7%, respectively. For pancreatic ductal adenocarcinoma (n=123), the benchmark for lymph node yield was ≥20. Higher surgical difficulty was associated with increased overall postoperative morbidity (R 2 =0.38, P =0.019), higher center caseload with reduced pancreas-specific complications (R 2 =0.28, P =0.044). Independent POPF predictors included duct diameter ≤4 mm (OR 1.37, 95% CI: 1.03, 1.82), anticoagulation (OR 2.45, 95% CI: 1.47, 3.99), and indication other than PDAC (OR 2.33, 95% CI: 1.68, 3.27). This study establishes the first international benchmarks for robotic Whipple, demonstrating oncologic outcomes and morbidity comparable to open surgery with the benefits of minimally invasive surgery.
Robotic-assisted resection of non-adenocarcinoma gastroduodenal tumors offers equivalent oncologic safety while preserving the benefits of minimally invasive surgery. Transoral extraction augments these benefits by reducing the need for a larger extraction incision. This study explores the feasibility of endoscopic transoral extraction of robotically resected gastroduodenal tumors. Patients underwent robotic gastroduodenal tumor resection by an experienced robotic surgeon. Resected specimens were secured in an EndoCatch bag and retrieved transorally using an upper gastrointestinal endoscope. Five patients (median age 46 years, 40
BACKGROUND:The optimal surgical technique for hepatocellular carcinoma (HCC) remains debated, particularly regarding the balance between perioperative morbidity and long-term oncological outcomes when comparing anatomical resection (AR) with non-anatomical resection (NAR). METHODS:This international, retrospective multicenter study included patients undergoing resection for solitary HCC ≤5 cm. Patients undergoing major hepatectomy (≥3 segments), two-stage hepatectomy, portal vein embolization, or non-curative procedures were excluded. After propensity score matching (PSM), perioperative outcomes, disease-free survival (DFS), and overall survival (OS) were analyzed, with subgroup analyses by surgical approach and tumour size. RESULTS:After propensity score matching, 442 patients were included in each group. NAR was associated with more favourable perioperative outcomes, including shorter operative time, lower blood loss, and lower rates of severe morbidity. DFS did not differ between groups. AR was associated with improved OS in the overall matched cohort (5-year OS: 77.2% vs. 67.2%; p = 0.041), in patients with larger tumours (≥3.6 cm; 81.3% vs. 61.3%; p = 0.022), and in those undergoing minimally invasive liver resection (74.5% vs. 63.2%; p = 0.001). No significant OS difference was observed in patients with smaller tumours (≤3.5 cm). CONCLUSION:NAR was associated with better perioperative outcomes, whereas AR was associated with improved OS in selected analyses. As DFS did not differ between groups and subgroup findings were exploratory, these results should be interpreted cautiously. Overall, the findings support an individualized, tumour-tailored surgical approach.
BACKGROUND:Robotic liver surgery (RLS) provides technical advantages over laparoscopic liver surgery, but no validated robotic-specific difficulty scoring system (DSS) exists. We evaluated the applicability of the Southampton DSS to RLS and developed a dedicated RLS difficulty model. STUDY DESIGN:This multicenter retrospective cohort study included adults undergoing planned RLS across 24 international hepatobiliary centers. The Southampton DSS was assessed for calibration and discrimination in predicting intraoperative complications. Given limited performance, a robotic-specific model (International RoboLiver DSS) was developed using multivariable logistic regression with prolonged operative time (more than 280 minutes; 75th percentile) as a surrogate of technical difficulty. Model discrimination, calibration, and bootstrap internal validation were performed. RESULTS:Among 1,497 RLS patients, higher Southampton DSS categories were associated with increased intraoperative complications (p = 0.003); however, discrimination was poor (area under the curve [AUC] 0.571, 95% CI 0.530 to 0.612) with miscalibration (slope 0.43; intercept 0.06). Independent predictors of prolonged operative time included neoadjuvant chemotherapy, earlier extrahepatic surgery, lesion greater than 50 mm, multiple lesions, bilobar disease, and technically or anatomically major resection. The International RoboLiver DSS demonstrated moderate discrimination (AUC 0.719, 95% CI 0.686 to 0.751) with excellent calibration (intercept 0.00; slope 1.14). Bootstrap validation confirmed model stability (corrected AUC 0.719). CONCLUSIONS:Difficulty factors in RLS partially overlap with laparoscopic liver surgery but are not directly transferable. The International RoboLiver DSS provides a calibrated, robot-specific tool for preoperative complexity stratification and operative planning in RLS. External validation is required.
OBJECTIVE:Recent changes have substantially impacted the assessment of medical students, including adjustments in clerkship grading and the transition of Step 1 to a pass/fail grading system in 2022. This study examines factors influencing students' decisions to take a gap year and the potential impact of assessment changes on the landscape of these decisions. DESIGN:This qualitative study used semi-structured interviews of medical students applying to surgical specialties to gather in-depth perspectives regarding their decision-making processes around taking or not taking a gap year. SETTING:We conducted virtual interviews with students from 5 U.S. medical schools located in the West, Midwest, Mid-Atlantic, and South. PARTICIPANTS:Interviewees comprised 25 senior medical students pursuing surgical specialties including general surgery, orthopedic surgery, neurosurgery, plastic surgery, and otolaryngology-head and neck surgery. RESULTS:We identified 5 main themes related to students' gap year decisions. Local institutional and specialty cultures set background expectations around gap years. Within these contexts, 3 dominant and often interrelated reasons motivated gap year decisions: the anticipated potential of a gap year to affect residency application competitiveness; personal, nonacademic circumstances; and the desire for professional growth. Regardless of students' gap year wishes, logistics ultimately dictated decisions for many students. CONCLUSIONS:In the context of evolving assessment systems, residency application competitiveness emerged as a primary factor influencing students' decisions to take a gap year. Students described that the transition of Step 1 to pass/fail led to fewer objective application metrics, with an ensuing focus on increased research productivity as a perceived differentiating factor amongst applicants. Personal and professional growth motivations remained present, but often played secondary roles in decision-making. For both gap year and traditional students, concerns regarding research years included variable access to funding, financial and temporal costs, and implications for delayed career and family timelines.
CENTRAL MESSAGE:Clinical practice guidance documents are not all the same. In digestive surgery, evidence-based guidelines, consensus statements, position papers, and protocols each serve different purposes, and the distinctions between them should be clear. Recognizing the strengths and limitations of each format is essential to improving decision-making, guiding research, and ultimately benefiting our patients. PERSPECTIVES:Digestive surgery evolves rapidly, and traditional publication models may not keep pace with emerging technologies and clinical demands. Future guidance documents are expected to incorporate artificial intelligence for evidence screening, living systematic reviews for continuous updates, and transparent digital repositories for open access to consensus voting and dissent. National registries and real-world data will complement trials where randomized evidence is scarce.
OBJECTIVE:To establish international benchmark values for relevant outcome parameters in robotic Whipple. SUMMARY BACKGROUND DATA:For safe adoption of surgical innovation, robust quality control is essential. Benchmarking is a validated tool for assessing surgical performance. Recent international consensus identified establishing benchmark values for robotic Whipple as top priority. METHODS:We analyzed consecutive patients undergoing robotic Whipple between 2020-2023 with a minimum one-year follow-up. Reference centers were required to perform ≥15 cases/year, be scientifically active in the field, and maintain a prospective database. Benchmark criteria included benign or resectable malignant disease without neoadjuvant therapy, arterial resection, major co-morbidities, or significant previous abdominal surgery. Benchmarks were established for 13 outcome parameters. RESULT:The benchmark cohort comprised 418 patients from 12 centers across four continents. Benchmark values were: conversion rate ≤4.3%, transfusion rate ≤2.1%, 6-month mortality ≤2.2%, major complications ≤23.2%, and CCI® ≤20.9. Clinically relevant pancreatic fistula (grade B/C) and hemorrhage (grade B/C) rates were ≤23.6% and ≤12.7%, respectively. For pancreatic ductal adenocarcinoma (n=123), the benchmark for lymph node yield was ≥20. Higher surgical difficulty was associated with increased overall postoperative morbidity (R2=0.38, P=0.019), higher center caseload with reduced pancreas-specific complications (R2=0.28, P=0.044). Independent POPF predictors included duct diameter ≤4 mm (OR 1.37, 95% CI: 1.03, 1.82), anticoagulation (OR 2.45, 95% CI: 1.47, 3.99), and indication other than PDAC (OR 2.33, 95% CI: 1.68, 3.27). CONCLUSIONS:This study establishes the first international benchmarks for robotic Whipple, demonstrating oncologic outcomes and morbidity comparable to open surgery with the benefits of minimally invasive surgery.
BACKGROUND:Conversion to open surgery forfeits any potential benefits of minimally invasive liver surgery (MILS), however, it remains uncertain whether the conversion itself introduces additional risk. The impact may differ depending on urgency (emergency or elective) and surgical approach (robotic or laparoscopic liver resection). This study aimed to evaluate outcomes of emergency and elective conversions in robotic liver resection (RLR) and laparoscopic liver resection (LLR). PATIENTS AND METHODS:Data from 34 international centers of patients undergoing converted MILS procedures (stratified for conversion urgency) were retrospectively compared with patients who underwent elective open liver surgery using propensity score matching. Additionally, RLR and LLR conversions were compared. Conversion risk factors were identified using multivariable logistic regression in RLR and LLR separately. RESULTS:Among 10,548 MILS procedures (n = 1626 RLR and n = 8922 LLR), 719 (6.8%) were converted. Both emergency (n = 226) and elective (n = 472) conversions were associated with longer operative time and more Pringle use compared with open surgery. Emergency conversions additionally showed higher blood loss, transfusion rates, severe morbidity, and even mortality. Matched analysis of 40 pairs of RLR and LLR conversions identified no significant differences in perioperative outcomes, although mortality following RLR conversion was remarkably high (7.7%). RLR conversion risk factors were bilobar disease and anatomically major resection; whereas LLR risk factors included cirrhosis, history of previous liver surgery, tumor size, technically complex, and anatomically major resection. CONCLUSIONS:Emergency conversions in MILS are associated with worse outcomes, whereas elective conversions appear safe, highlighting the importance of timely, controlled conversion. Further investigation into the safety of robotic conversions is warranted.
BACKGROUND:Although minimally invasive surgery is widely accepted across surgical disciplines, its role in pancreatic cancer continues to be debated. The objective of the São Paulo Consensus on Minimally Invasive Pancreatic Surgery (MIPS) was to establish consensus statements on the use of MIPS for pancreatic cancer, integrating contemporary evidence and recent advances. METHODS:A scoping literature review informed statement development across five thematic groups: (1) Left Pancreatectomy for Pancreatic Cancer, (2) Pancreatoduodenectomy and Total Pancreatectomy for Pancreatic Cancer, (3) Neuroendocrine Pancreatic Tumors, (4) Patient Evaluation and Surgical Technique, and (5) Implementation, Training, and Innovation. A three-round modified Delphi process was conducted with an international panel of 52 expert pancreas surgeons. Consensus was defined as ≥90 % agreement. RESULTS:From 2590 publications, 185 studies were selected for inclusion. Fifty-two hepatopancreatobiliary surgeons, with a median of 22 years of experience, achieved consensus through a three-round Delphi process. Ultimately, 22 of the initial 28 statements met the ≥90 % agreement threshold. The resulting recommendations provide evidence-based guidance on minimally invasive pancreas resection for cancer, including neuroendocrine tumors, patient evaluation, program implementation, and innovation. DISCUSSION:The São Paulo Consensus provides contemporary, evidence-based recommendations to guide the safe and judicious adoption, implementation, and practice of minimally invasive techniques.
The DIPLOMA trial showed comparable radical resection rates after minimally invasive left pancreatectomy (MILP) and open left pancreatectomy (OLP) in patients with upfront resectable pancreatic cancer. Data on long-term overall survival (OS) and disease-free survival (DFS) are currently lacking, but are required before the oncological efficacy of MILP can be confirmed. To determine the long-term oncological outcome, including OS and DFS, of MILP vs OLP in patients with upfront resectable left-sided pancreatic cancer in the DIPLOMA trial. The randomized, patient-blinded and pathologist-blinded DIPLOMA trial was conducted between 2018 and 2021, with a follow-up duration of at least 36 months. It was a multicenter international trial that took place in 35 centers in 12 countries worldwide. Patients with upfront resectable pancreatic ductal adenocarcinoma of the body or tail of the pancreas were included. Participants were randomly assigned to undergo MILP (laparoscopic and robotic) or OLP. Patients were blinded for the surgical approach. Main outcomes included OS and DFS. Other outcomes include receipt of adjuvant therapy and time to start of adjuvant therapy. Between May 2018 and May 2021, 258 patients were randomized to the MILP (131 patients) and OLP (127 patients) groups. After a median follow-up of 38 (IQR 36-46) months, 134 patients (52%) had died and 127 patients (55%) experienced disease recurrence. OS did not differ significantly between the MILP and OLP groups (median, 32 vs 34 months; stratified hazard ratio, 1.02; 95% CI, 0.72-1.44; P = .92). Also, DFS did not significantly differ between the MILP and OLP groups (median, 21 vs 17 months; stratified hazard ratio, 0.96; 95% CI, 0.68-1.35; P = .81). Adjuvant therapy was administered in 79 patients after MILP (79 of 113 [70%]) and 79 patients after OLP (79 of 110 [72%]) ( P = .63). Time to adjuvant therapy was comparable between groups (median 59 vs 56 days; P = .92). In this long-term follow-up of the randomized DIPLOMA trial in patients with upfront resectable pancreatic cancer, oncological outcomes after MILP and OLP did not differ significantly, confirming the oncological safety of MILP. International Standard Registered Clinical/Social Study Number Registry Identifier: ISRCTN44897265
IMPORTANCE:The lack of multidisciplinary workflow guidelines and clear definitions and classifications for neoplasms in and around the ampulla of Vater results in inconsistencies affecting patient care and research. OBJECTIVE:The PERIPAN international multidisciplinary consensus group aimed to standardize the multidisciplinary diagnostic workflow and achieve consensus on definitions and classifications in order to ensure proper classification and optimal diagnostic assessment and consequently to improve patient care and future research. DESIGN:An international team of 43 experts (pathologists, surgeons, radiologists, gastroenterologists, oncologists) from 12 countries identified knowledge gaps, reviewed 37061 articles, and proposed recommendations using the Scottish Intercollegiate Guidelines Network methodology (SIGN), including the Delphi methodology and the AGREEII tool for quality assessment and external validation. RESULTS:The 38 consensus questions and 51 recommendations provide guidance on the following key aspects: I. More specific anatomic criteria for the definition of what qualifies as "ampullary" neoplasms, their distinction from duodenal and common bile duct tumors, and clinicopathologic characteristics of anatomic subsets; II. Avoidance of the confusing term "periampullary" for final classification; III. Refined definitions of intestinal, pancreatobiliary and mixed subtypes, and introduction of rare histologic subtypes; IV. The use and limitations of immunohistochemical and molecular profiling; V. Biopsy acquisition; VI. Clinical information required for accurate pathology assessment of biopsies and ampullectomy specimens; VII. Key items to be included in pathology reports of endoscopic specimens. CONCLUSIONS AND RELEVANCE:Recognition of the Brescia PERIPAN guidelines will allow a more accurate classification of true ampullary cancers and their differentiation from other "periampullary" tumors. This will have significant implications for endoscopic interpretation and management, staging, pathologic diagnosis and therapeutic evaluation as well as oncologic treatment of various anatomic and histologic subsets of ampullary tumors. This will enhance the quality of both clinical care and future research in this complex medical field.