Advancing minimally invasive hepato-pancreato-biliary surgery: ensuring safety with implementation.

BACKGROUND: Although minimally invasive hepato-pancreato-biliary (MIS HPB) surgery can be performed with good outcomes, there are currently no standardized requirements for centers or surgeons who wish to implement MIS HPB surgery. The aim of this study was to create a consensus statement regarding safe dissemination and implementation of MIS HPB surgical programs. METHODS: Sixteen key questions regarding safety in MIS HPB surgery were generated after a focused literature search and iterative review by three field experts. Participants for the working group were then selected using sequential purposive sampling and snowball techniques. Review of the 16 questions took place over a single 2-h meeting. The senior author facilitated the session, and a modified nominal group technique was used. RESULTS: Twenty three surgeons were in attendance. All participants agreed or strongly agreed that formal guidelines should exist for both institutions and individual surgeons interested in implementing MIS HPB surgery and that routine monitoring and reporting of institutional and surgeon technical outcomes should be performed. Regarding volume cutoffs, most participants (91%) agreed or strongly agreed that a minimum annual institutional volume cutoff for complex MIS HPB surgery, such as major hepatectomy or pancreaticoduodenectomy, should exist. A smaller proportion (74%) agreed or strongly agreed that a minimum annual surgeon volume requirement should exist. The majority of participants agreed or strongly agreed that surgeons were responsible for defining (100%) and enforcing (78%) guidelines to ensure the overall safety of MIS HPB programs. Finally, formal MIS HPB training, minimum case volume requirements, institutional support and infrastructure, and mandatory collection of outcomes data were all recognized as important aspects of safe implementation of MIS HPB surgery. CONCLUSIONS: Safe implementation of MIS HPB surgery requires a thoughtful process that incorporates structured training, sufficient volume and expertise, a proper institutional ecosystem, and monitoring of outcomes.

The joy of surgery: how surgeons experience joy, time, and support.

BACKGROUND: Burnout is a crisis in medicine, and especially in surgery it has serious implications not only for physician well-being but also for patient outcomes. This study builds on previous SAGES Reimagining the Practice of Surgery Task Force work to better understand how organizations might intervene to increase the "joy in surgery." METHODS: This was a cross-sectional, descriptive study utilizing a REDCap survey with closed-ended questions for data collection across 5 domains: facilitators of joy, support for best work, time for work tasks, barriers to joy, and what they would do with more time. We calculated average scores and "percentage of respondents giving a high score" for each item. RESULTS: There were 307 individuals who started the survey; 223 completed it and were surgeons who met the inclusion criteria. The majority (85.7%) were trained in general surgery, regardless of sub-specialty. Surgeons found joy in operating and its technical skills, curing disease, patient relationships, and working with a good team. They reported usually having what they needed to deliver care. A majority felt valued and respected. Most were dissatisfied with reimbursement, perceiving it as unfair. The most commonly worked range of hours was 51-70 per week. They reported having little time for paperwork and documentation, and if they had more time, they would spend it with friends and family. CONCLUSION: Organizations should consider interventions to address the operative environment, provide appropriate staff support, and foster good teamwork. They can also consider interventions that alleviate time pressures and administrative burden while at the same time promoting sustainable workloads.

The joy of surgery: how gender influences surgeons' experiences.

INTRODUCTION: Burnout in medicine is an epidemic, and surgeons are not immune. Studies often focus on negative factors leading to burnout, with less emphasis on optimizing joy. The purpose of this study, conducted by the SAGES Reimagining the Practice of Surgery Task Force, was to explore how gender may influence surgeon well-being to better inform organizational change. METHODS: The study team developed a survey with the domains: facilitators of joy, support for best work, time for work tasks, barriers to joy, and what they would do with more time. The survey was emailed to 5777 addresses on the SAGES distribution list. Results were analyzed by calculating summary statistics. RESULTS: 223 surgeons completed the survey; 62.3% identified as men, 32.3% as women, and 5.4% did not indicate gender. Female compared to male respondents were younger (41.6 vs 52.5 years) and had practiced for fewer years (8.4 vs 19.4 years). The three greatest differences in facilitators of joy were being a leader in the field, leading clinical teams, and teaching, with a > 10 percentage point difference between men/women rating these highly (score of ≥ 8). Women generally perceived less support from their institutions than men. The greatest gender difference was in support for teaching, with 52.8% of men rating this highly compared to 30.2% of women. Only 52% of women felt respected by coworkers most of the time compared to 68.3% of men. Most (96.0%) respondents (men 95.7% and women 98.6%) reported wanting more time with family and friends. CONCLUSION: This study demonstrates the complexity of the personal and professional factors that influence joy in surgery, highlight gender differences that impact joy and suggests opportunities for improved gender-based support. These results can inform potential organization-level changes and further research to better understand emerging differences in joy across gender identities.

REDISCOVER guidelines for borderline-resectable and locally advanced pancreatic cancer: management algorithm, unanswered questions, and future perspectives.

The REDISCOVER guidelines present 34 recommendations for the selection and perioperative care of borderline-resectable (BR-PDAC) and locally advanced ductal adenocarcinoma of the pancreas (LA-PDAC). These guidelines represent a significant shift from previous approaches, prioritizing tumor biology over anatomical features as the primary indication for resection. Condensed herein, they provide a practical management algorithm for clinical practice. However, the guidelines also highlight the need to redefine LA-PDAC to align with modern treatment strategies and to solve some contradictions within the current definition, such as grouping "difficult" and "impossible" to resect tumors together. Furthermore, the REDISCOVER guidelines highlight several areas requiring urgent research. These include the resection of the superior mesenteric artery, the management strategies for patients with LA-PDAC who are fit for surgery but unable to receive multi-agent neoadjuvant chemotherapy, the approach to patients with LA-PDAC who are fit for surgery but demonstrate high serum Ca 19.9 levels even after neoadjuvant treatment, and the optimal timing and number of chemotherapy cycles prior to surgery. Additionally, the role of primary chemoradiotherapy versus chemotherapy alone in LA-PDAC, the timing of surgical resection post-neoadjuvant/primary chemoradiotherapy, the efficacy of ablation therapies, and the management of oligometastasis in patients with LA-PDAC warrant investigation. Given the limited evidence for many issues, refining existing management strategies is imperative. The establishment of the REDISCOVER registry ( https://rediscover.unipi.it/ ) offers promise of a unified research platform to advance understanding and improve the management of BR-PDAC and LA-PDAC.

Incidence and outcomes of postoperative fluid collections after minimally invasive distal pancreatectomy without placement of surgical drain. A prospective observational cohort study.

BACKGROUND/PURPOSE: There is uncertainty about the role of prophylactic intra-abdominal drains after distal pancreatectomy. In the present study, we aimed to describe the long-term outcomes of postoperative pancreatic collections in patients who underwent a minimally invasive distal pancreatectomy (MIDP) without surgical drain placement. METHODS: From 2018 to 2022, consecutive patients who underwent a MIDP were recorded. Patients were followed at 90 days, 6 months, and in the long term. The use of interventional procedures and antibiotic therapy were documented, and the overall evolution of the collections was assessed. RESULTS: A total of 91 patients underwent MIDP; 11 were excluded; 80 were analyzed. Median age was 63 (51-73) years; 61.3% were women. Most lesions (71.3%) were malignant; 15 patients received neoadjuvant therapy. Procedures were laparoscopic (87.5%) or robotic (12.5%). Incidence of postoperative pancreatic collections was 33%; 10 patients were symptomatic. Interventional endoscopic (n = 3) or percutaneous (n = 3) procedures were required. At a follow-up of 24 (17.5-33.1) months, 18 collections resolved completely, eight partially, and one increased. CONCLUSIONS: Patients who undergo MIDP without surgical drain placement develop well-tolerated pancreatic collections. Although a minority may require endoscopic or percutaneous drainage, the majority can be managed conservatively and resolve spontaneously in the long term.

Prophylactic abdominal drainage after distal pancreatectomy (PANDORINA): an international, multicentre, open-label, randomised controlled, non-inferiority trial.

BACKGROUND: Prophylactic passive abdominal drainage is standard practice after distal pancreatectomy. This approach aims to mitigate the consequences of postoperative pancreatic fistula (POPF) but its added value, especially in patients at low risk of POPF, is currently being debated. We aimed to assess the non-inferiority of a no-drain policy in patients after distal pancreatectomy. METHODS: In this international, multicentre, open-label, randomised controlled, non-inferiority trial, we recruited patients aged 18 years or older undergoing open or minimally invasive elective distal pancreatectomy for all indications in 12 centres in the Netherlands and Italy. We excluded patients with an American Society of Anesthesiology (ASA) physical status of 4-5 or WHO performance status of 3-4, added by amendment following the death of a patient with ASA 4 due to a pre-existing cardiac condition. Patients were randomly assigned (1:1) intraoperatively by permuted blocks (size four to eight) to either no drain or prophylactic passive drain placement, stratified by annual centre volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High-risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score. Other patients were considered low-risk. The primary outcome was the rate of major morbidity (Clavien-Dindo score ≥III), and the most relevant secondary outcome was grade B or C POPF, grading per the International Study Group for Pancreatic Surgery. Outcomes were assessed up to 90 days postoperatively and analysed in the intention-to-treat population and per-protocol population, which only included patients who received the allocated treatment. A prespecified non-inferiority margin of 8% was compared with the upper limit of the two-sided 95% CI (Wald) of unadjusted risk difference to assess non-inferiority. This trial is closed and registered in the Netherlands Trial Registry, NL9116. FINDINGS: Between Oct 3, 2020, and April 28, 2023, 376 patients were screened for eligibility and 282 patients were randomly assigned to the no-drain group (n=138; 75 [54%] women and 63 [46%] men) or the drain group (n=144; 73 [51%] women and 71 [49%] men). Seven patients in the no-drain group received a drain intraoperatively; consequently, the per-protocol population included 131 patients in the no-drain group and 144 patients in the drain group. The rate of major morbidity was non-inferior in the no-drain group compared with the drain group in the intention-to-treat analysis (21 [15%] vs 29 [20%]; risk difference -4·9 percentage points [95% CI -13·8 to 4·0]; pnon-inferiority=0·0022) and the per-protocol analysis (21 [16%] vs 29 [20%]; risk difference -4·1 percentage points [-13·2 to 5·0]; pnon-inferiority=0·0045). Grade B or C POPF was observed in 16 (12%) patients in the no-drain group and in 39 (27%) patients in the drain group (risk difference -15·5 percentage points [95% CI -24·5 to -6·5]; pnon-inferiority<0·0001) in the intention-to-treat analysis. Three patients in the no-drain group died within 90 days; the cause of death in two was not considered related to the trial. The third death was a patient with an ASA score of 4 who died after sepsis and a watershed cerebral infarction at second admission, leading to multiple organ failure. No patients in the drain group died within 90 days. INTERPRETATION: A no-drain policy is safe in terms of major morbidity and reduced the detection of grade B or C POPF, and should be the new standard approach in eligible patients undergoing distal pancreatectomy. FUNDING: Ethicon UK (Johnson & Johnson Medical, Edinburgh, UK).

Intraductal papillary neoplasms of the bile ducts: a comparative study of a rare disease in Europe and Nagoya, Japan.

BACKGROUND: Intraductal papillary neoplasm of the bile ducts (IPNB) is a rare disease in Western countries. The aim of this study was to compare tumor characteristics, management strategies, and outcomes between Western and Eastern patients who underwent surgical resection for IPNB. METHODS: A multi-institutional retrospective series of patients with IPNB undergoing surgery between January 2010 and December 2020 was gathered under the auspices of the European-African Hepato-Pancreato-Biliary Association (E-AHPBA), and at Nagoya University Hospital, Japan. RESULTS: A total of 85 patients (51% male; median age 66 years) from 28 E-AHPBA centers were compared to 91 patients (64% male; median age 71 years) from Nagoya. Patients in Europe had more multiple lesions (23% vs 2%, P < .001), less invasive carcinoma (42% vs 85%, P < .001), and more intrahepatic tumors (52% vs 24%, P < .001) than in Nagoya. Patients in Europe experienced less 90-day grade >3 Clavien-Dindo complications (33% vs 68%, P < .001), but higher 90-day mortality rate (7.0% vs 0%, P = .03). R0 resections (81% vs 82%) were similar. Overall survival, excluding 90-day postoperative deaths, was similar in both regions. DISCUSSION: Despite performing more extensive resections, the low perioperative mortality rate observed in Nagoya was probably influenced by a combination of patient-, tumor-, and surgery-related factors.

Autogenic splenic implantation versus splenectomy in patients undergoing distal pancreatectomy for benign or low-grade malignant lesions of the distal pancreas: study protocol for a multicentre, open-label, randomized controlled trial (RESTORE).

BACKGROUND: The spleen plays a significant role in the clearance of circulating microorganisms. Sequelae of splenectomy, especially immunodeficiency, can have a deleterious effect on a patient's health and even lead to death. Hence, splenectomy should be avoided and spleen preservation during elective surgery has become a treatment goal. However, this cannot be achieved in every patient due to intraoperative technical difficulties or oncological reasons. Autogenic splenic implantation (ASI) is currently the only possible way to preserve splenic function when a splenectomy is necessary. Experience largely stems from trauma patients with a splenic rupture. Splenic immune function can be measured by the body's clearing capacity of encapsulated bacteria. The aim of this study is to assess the splenic immune function after ASI was performed during minimally invasive (laparoscopic or robotic) distal pancreatectomy with splenectomy. METHODS: This is the protocol for a multicentre, randomized, open-labelled trial. Thirty participants with benign or low-grade malignant lesions of the distal pancreas requiring minimally invasive distal pancreatectomy and splenectomy will be allocated to either additional intraoperative ASI (intervention) or no further intervention (control). An additional 15 patients who will undergo spleen-preserving distal pancreatectomy serve as the control group with normal splenic function. Six months postoperatively, after assumed restoration of splenic function, patients will be given a Salmonella typhi (Typhim Vi™) vaccine. The Salmonella typhi vaccine is a polysaccharide vaccine. The specific antibody titres immediately before and 4 to 6 weeks after vaccination will be measured. The ratio between pre- and post-vaccination antibody count is the primary outcome measure and secondary outcome measures include intraoperative details, length of hospital stay, 30-day mortality and morbidity. DISCUSSION: This study will investigate the splenic immune function of patients who undergo ASI during minimally invasive distal pancreatectomy with splenectomy. The splenic immune function will be measured using the surrogate outcome of specific antibody titre after vaccination with a Salmonella typhi vaccine. The results will reveal details about splenic function after ASI and guide further treatment options for patients when a splenectomy cannot be avoided. It might eventually lead to a new standard of care making sometimes more demanding and time-consuming spleen-preserving procedures redundant. TRIAL REGISTRATION: International Standard Randomized Controlled Trials Number (ISRCTN) ISRCTN10171587. Prospectively registered on 18 February 2019.

International survey on opinions and use of robot-assisted and laparoscopic minimally invasive pancreatic surgery: 5-year follow up.

BACKGROUND: Evidence on the value of minimally invasive pancreatic surgery (MIPS) has been increasing but it is unclear how this has influenced the view of pancreatic surgeons on MIPS. METHODS: An anonymous survey was sent to members of eight international Hepato-Pancreato-Biliary Associations. Outcomes were compared with the 2016 international survey. RESULTS: Overall, 315 surgeons from 47 countries participated. The median volume of pancreatic resections per center was 70 (IQR 40-120). Most surgeons considered minimally invasive distal pancreatectomy (MIDP) superior to open (ODP) (94.6%) and open pancreatoduodenectomy (OPD) superior to minimally invasive (MIPD) (67.9%). Since 2016, there has been an increase in the number of surgeons performing both MIDP (79%-85.7%, p = 0.024) and MIPD (29%-45.7%, p < 0.001), and an increase in the use of the robot-assisted approach for both MIDP (16%-45.6%, p < 0.001) and MIPD (23%-47.9%, p < 0.001). The use of laparoscopy remained stable for MIDP (91% vs. 88.1%, p = 0.245) and decreased for MIPD (51%-36.8%, p = 0.024). CONCLUSION: This survey showed considerable changes of MIPS since 2016 with most surgeons considering MIDP superior to ODP and an increased use of robot-assisted MIPS. Surgeons prefer OPD and therefore the value of MIPD remains to be determined in randomized trials.

Preoperative CA19.9 level predicts lymph node metastasis in resectable adenocarcinoma of the head of the pancreas: A further plea for biological resectability criteria.

INTRODUCTION: Lymph-nodal involvement (N+) represents an adverse prognostic factor after pancreatoduodenectomy (PD) for pancreatic adenocarcinoma (PDAC). Preoperative diagnostic and staging modalities lack sensitivity for identifying N+. This study aimed to investigate preoperative CA19.9 in predicting the N+ stage in resectable-PDAC (R-PDAC). METHODS: Patients included in a multi-institutional retrospective database of PDs performed for R-PDAC from January 2000 to June 2021 were analyzed. A preoperative laboratory value of CA19.9 >37 U/L was used in univariate and multivariate logistic regression analysis to determine a possible association with N+. Additionally, different cut-offs of CA19.9 related to the preoperative clinical T (cT) stage was assessed to evaluate the risk of N+. RESULTS: A total of 2034 PDs from thirteen centers were included in the study. CA19.9>37 U/L was significantly associated with higher N+ at univariate and multivariate analysis (P<0.001). CA19.9 levels >37 U/L were associated with N+ in 75.9%, 81.3%, and 85.7% of patients, respectively, in cT1, cT2, and cT3 tumors and with higher cut-off values for all cT stages. CONCLUSION: Lymph nodal involvement is strongly related to preoperative CA19.9 levels. Specially in patients staged as cT3 the CA 19.9 could represent a valid and easy tool to suspect nodal involvement. Due to these findings, R-PDAC patients with elevated CA19.9 values should be considered in a more biologically advanced stage.

Lymph Node Dissection in Intrahepatic Cholangiocarcinoma: a Critical and Updated Review of the Literature.

BACKGROUND: Lymphatic spread of intrahepatic cholangiocarcinoma (iCCA) is common and negatively impacts survival. However, the precise role of lymph node dissection (LND) in oncologic outcomes for patients with intrahepatic cholangiocarcinoma remains to be established. METHODS: Updated evidence on the preoperative diagnosis and prognostic value of lymph node metastasis is reviewed, as well as the potential benefit of LND in patients with iCCA. RESULTS: The ability to accurately determine nodal status for iCCA with current imaging modalities is equivocal. LND has prognostic value for both survival and disease recurrence. However, execution rates of LND are highly varied in the literature, ranging from 26.9 to 100%. At least 6 lymph nodes should be examined from nodal stations of the hepatoduodenal ligament and hepatic artery as well as based on the location of the primary tumor. Neoadjuvant therapies may be beneficial if lymph node metastases at diagnosis are suspected. Surgeons performing a minimally invasive approach should focus on increasing LND rates and harvesting ≥ 6 lymph nodes. Lymph node negativity is required in patients with iCCA being considered for liver transplantation under investigational protocols. CONCLUSION: Despite an upward trend in the LND rate, the reality is that only 10% of patients with iCCA receive an adequate LND. This review underscores the importance of routinely increasing the rate of adequate LND in these patients in order to achieve accurate staging, appropriately select patients for adjuvant therapy, and improve the prognosis of clinical outcomes. While prospective data is lacking, the therapeutic impact of LND remains unknown.

Factors influencing surgeon well-being: qualitatively exploring the joy of surgery.

BACKGROUND: There has been considerable research into burnout but much less into how surgeons thrive and find joy. This study, conducted by the SAGES Reimagining the Practice of Surgery Task Force, explored factors influencing surgeon well-being, the eventual goal being translating findings into tangible changes to help restore the joy in surgery. METHODS: This was a qualitative, descriptive study. Purposive sampling ensured representation across ages, genders, ethnicities, practice types, and geographies. Semi-structured interviews were recorded and transcribed. We coded inductively, finalized the codebook by consensus, and then constructed a thematic network. Global themes formed our conclusions; organizing themes gave additional detail. Analysis was facilitated by NVivo. RESULTS: We interviewed 17 surgeons from the US and Canada. Total interview time was 15 hours. Our global and organizing themes were: Stressors (Work-life Integration, Administration-related Concerns, Time and Productivity Pressures, Operating Room Factors, and Lack of Respect). Satisfaction (Service, Challenge, Autonomy, Leadership, and Respect and Recognition). Support (Team, Personal Life, Leaders, and Institutions). Values (Professional and Personal). Suggestions (Individual, Practice, and System level). Values, stressors, and satisfaction influenced perspectives on support. Experiences of support shaped suggestions. All participants reported stressors and satisfiers. Surgeons at all stages enjoyed operating and being of service. Supports and suggestions included compensation and infrastructure, but human resources were most critical. To experience joy, surgeons needed high-functioning clinical teams, good leaders/mentors, and supportive family/social networks. CONCLUSIONS: Our results indicated organizations could (1) better understand surgeons' values, like autonomy; (2) provide more time for satisfiers, like patient relationship building; (3) minimize stressors, like time and financial pressures; and (4) at all levels focus on (4a) building teams and leaders and (4b) giving surgeons time and space for healthy family/social lives. Next steps include developing an assessment tool for individual institutions to build "joy improvement plans" and to inform surgical associations' advocacy efforts.

SAGES SAFE CHOLE program changes surgeons practice in France-results of the FCVD implementation of SAFE CHOLE in France.

BACKGROUND: With the Society of Gastrointestinal and Endoscopic Surgeons supervision, the Safe Cholecystectomy Task Force (SAFE CHOLE) was translated into French by the the Federation of Visceral and Digestive Surgery (FCVD) and adopted to run on its national e-learning platform for surgical continuing medical education (CME). The objective of this study was to assess the impact of the SAFE CHOLE (SF) program on the knowledge and practice of French surgeons performing cholecystectomy and participating in the FCVD lead CME activity. METHODS: To obtain CME certification, each participant must fill out three FCVD validated questionnaires regarding (1) the participants' routine practice for cholecystectomy, (2) the participants' knowledge and practice after successful completion of the program, and (3) the educational value of the SC program. RESULTS: From 2021 to 2022, 481 surgeons completed the program. The overall satisfaction rate for the program was 81%, and 53% of the surgeons were practicing routine cholangiography before the SC program. Eighty percent declared having acquired new knowledge. Fifty-six percent reported a change in their practice of cholecystectomy. Of those, 46% started routinely using the critical view of safety, 12% used a time-out prior transection of vital structures, and 11% adopted routine intraoperative cholangiography. Sixty-seven percent reported performing a sub-total cholecystectomy in case the CVS was unobtainable. If faced with BDI, 45% would transfer to a higher level of care, 33% would seek help from a colleague, and 10% would proceed with a repair. Ninety percent recommended adoption of SC by all general surgeons and 98% reported improvement of patient safety. CONCLUSIONS: Large-scale implementation of the SC program in France is feasible within a broad group of diverse specialty surgeons and appears to have a significant impact on their practice. These data should encourage other surgeons and health systems to engage in this program.

Intraductal papillary neoplasms of the bile duct: a European retrospective multicenter observational study (EUR-IPNB study).

BACKGROUND/PURPOSE: Intraductal papillary neoplasm of the bile duct (IPNB) is a rare disease in Western countries. The main aim of this study was to characterize current surgical strategies and outcomes in the mainly European participating centers. METHODS: A multi-institutional retrospective series of patients with a diagnosis of IPNB undergoing surgery between 1 January 2010 and 31 December 2020 was gathered under the auspices of the European-African Hepato-Pancreato-Biliary Association. The textbook outcome (TO) was defined as a non-prolonged length of hospital stay plus the absence of any Clavien-Dindo grade at least III complications, readmission, or mortality within 90 postoperative days. RESULTS: A total of 28 centers contributed 85 patients who underwent surgery for IPNB. The median age was 66 years (55-72), 49.4% were women, and 87.1% were Caucasian. Open surgery was performed in 72 patients (84.7%) and laparoscopic in 13 (15.3%). TO was achieved in 54.1% of patients, reaching 63.8% after liver resection and 32.0% after pancreas resection. Median overall survival was 5.72 years, with 5-year overall survival of 63% (95% CI: 50-82). Overall survival was better in patients with Charlson comorbidity score 4 or less versus more than 4 ( P =0.016), intrahepatic versus extrahepatic tumor ( P =0.027), single versus multiple tumors ( P =0.007), those who underwent hepatic versus pancreatic resection ( P =0.017), or achieved versus failed TO ( P =0.029). Multivariable Cox regression analysis showed that not achieving TO (HR: 4.20; 95% CI: 1.11-15.94; P =0.03) was an independent prognostic factor of poor overall survival. CONCLUSIONS: Patients undergoing liver resection for IPNB were more likely to achieve a TO outcome than those requiring a pancreatic resection. Comorbidity, tumor location, and tumor multiplicity influenced overall survival. TO was an independent prognostic factor of overall survival.

SAGES perspective: professional medical associations, commercial interests, and conflicts of interest.

BACKGROUND: Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound. METHODS: SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009-2021. RESULTS: Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4-6.2% (2008-2010) to 1.2-2.2% (2011-2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity. CONCLUSIONS: The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.

Educational Scoring System in Laparoscopic Cholecystectomy: Is It the Right Time to Standardize?

Background and Objectives: Laparoscopic cholecystectomy (LC) is one of the most performed surgeries worldwide. Procedure difficulty and patient outcomes depend on several factors which are not considered in the current literature, including the learning curve, generating confusing and subjective results. This study aims to create a scoring system to calculate the learning curve of LC based on hepatobiliopancreatic (HPB) experts' opinions during an educational course. Materials and Methods: A questionnaire was submitted to the panel of experts attending the HPB course at Research Institute against Digestive Cancer-IRCAD (Strasbourg, France) from 27-29 October 2022. Experts scored the proposed variables according to their degree of importance in the learning curve using a Likert scale from 1 (not useful) to 5 (very useful). Variables were included in the composite scoring system only if more than 75% of experts ranked its relevance in the learning curve assessment ≥4. A positive or negative value was assigned to each variable based on its effect on the learning curve. Results: Fifteen experts from six different countries attended the IRCAD HPB course and filled out the questionnaire. Ten variables were finally included in the learning curve scoring system (i.e., patient body weight/BMI, patient previous open surgery, emergency setting, increased inflammatory levels, presence of anatomical bile duct variation(s), and appropriate critical view of safety (CVS) identification), which were all assigned positive values. Minor or major intraoperative injuries to the biliary tract, development of postoperative complications related to biliary injuries, and mortality were assigned negative values. Conclusions: This is the first scoring system on the learning curve of LC based on variables selected through the experts' opinions. Although the score needs to be validated through future studies, it could be a useful tool to assess its efficacy within educational programs and surgical courses.

Survey on initial management of acute pancreatitis in Latin America.

OBJECTIVE: The population of Latin America harbors the highest incidence of gallstones and acute biliary pancreatitis, yet little is known about the initial management of acute pancreatitis in this large geographic region. PARTICIPANTS AND METHODS: We performed a post hoc analysis of responses from physicians based in Latin America to the international multidisciplinary survey on the initial management of acute pancreatitis. The questionnaire asked about management of patients during the first 72h after admission, related to fluid therapy, prescription of prophylactic antibiotics, feeding and nutrition, and timing of cholecystectomy. Adherence to clinical guidelines in this region was compared with the rest of the world. RESULTS: The survey was completed by 358 participants from 19 Latin American countries (median age, 39 years [33-47]; women, 27.1%). The proportion of participants in Latin America vs. the rest of the world who chose non-compliant options with clinical guidelines were: prescription of fluid therapy rate other than moderate (42.2% vs 34.3%, P=.02); prescription of prophylactic antibiotics for severe (10.6% vs 18.0%, P=.002), necrotizing (28.5% vs 36.9%, P=.008), or systemic inflammatory response syndrome-associated (21.2% vs 30.6%, P=.002) acute pancreatitis; not starting an oral diet to patients with oral tolerance (77.9% vs 71.1%, P=.02); and delayed cholecystectomy (16.2% vs 33.8%, P<.001). CONCLUSIONS: Surveyed physicians in Latin America are less likely to prescribe antibiotics and to delay cholecystectomy when managing patients in the initial phase of acute pancreatitis compared to physicians in the rest of the world. Feeding and nutrition appear to require the greatest improvement.

SAGES/AHPBA guidelines for the use of minimally invasive surgery for the surgical treatment of colorectal liver metastases (CRLM).

BACKGROUND: Colorectal liver metastases (CRLM) occur in roughly half of patients with colorectal cancer. Minimally invasive surgery (MIS) has become an increasingly acceptable and utilized technique for resection in these patients, but there is a lack of specific guidelines on the use of MIS hepatectomy in this setting. A multidisciplinary expert panel was convened to develop evidence-based recommendations regarding the decision between MIS and open techniques for the resection of CRLM. METHODS: Systematic review was conducted for two key questions (KQ) regarding the use of MIS versus open surgery for the resection of isolated liver metastases from colon and rectal cancer. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Additionally, the panel developed recommendations for future research. RESULTS: The panel addressed two KQs, which pertained to staged or simultaneous resection of resectable colon or rectal metastases. The panel made conditional recommendations for the use of MIS hepatectomy for both staged and simultaneous resection when deemed safe, feasible, and oncologically effective by the surgeon based on the individual patient characteristics. These recommendations were based on low and very low certainty of evidence. CONCLUSIONS: These evidence-based recommendations should provide guidance regarding surgical decision-making in the treatment of CRLM and highlight the importance of individual considerations of each case. Pursuing the identified research needs may help further refine the evidence and improve future versions of guidelines for the use of MIS techniques in the treatment of CRLM.

Multi-Institutional Outcomes of Patients Aged 75 years and Older With Pancreatic Ductal Adenocarcinoma Treated With 5-Fraction Ablative Stereotactic Magnetic Resonance Image-Guided Adaptive Radiation Therapy (A-SMART).

PURPOSE: Treatment options for pancreatic ductal adenocarcinoma (PDAC) are commonly limited for patients with advanced age due to medical comorbidities and/or poor performance status. These patients may not be candidates for more aggressive chemotherapy regimens and/or surgical resection leaving few, if any, other effective treatments. Ablative stereotactic MRI-guided adaptive radiation therapy (A-SMART) is both efficacious and safe for PDAC and can achieve excellent long-term local control, however, the appropriateness of A-SMART for elderly patients with inoperable PDAC is not well understood. METHODS: A retrospective analysis was performed of inoperable non-metastatic PDAC patients aged 75 years or older treated on the MRIdian Linac at 2 institutions. Clinical outcomes of interest included overall survival (OS), progression-free survival (PFS), distant metastasis-free survival (DMFS), and locoregional (LRC). Toxicity was graded according to Common Terminology Criteria for Adverse Events (CTCAE, v5). RESULTS: A total of 49 patients were evaluated with a median age of 81 years (range, 75-91) and a median follow-up of 14 months from diagnosis. PDAC was classified as locally advanced (46.9%), borderline resectable (36.7%), or medically inoperable (16.3%). Neoadjuvant chemotherapy was delivered to 84% of patients and all received A-SMART to a median 50 Gy (range, 40-50 Gy) in 5 fractions. 1 Year LRC, PFS, and OS were 88.9%, 53.8%, and 78.9%, respectively. Nine patients (18%) had resection after A-SMART and benefited from PFS improvement (26 vs 6 months, P = .01). ECOG PS <2 was the only predictor of improved OS on multivariate analysis. Acute and late grade 3 + toxicity rates were 8.2% and 4.1%, respectively. CONCLUSIONS: A-SMART is associated with encouraging LRC and OS in elderly patients with initially inoperable PDAC. This novel non-invasive treatment strategy appears to be well-tolerated in patients with advanced age and should be considered in this population that has limited treatment options.