The miami international evidence-based guidelines on minimally invasive pancreas resection

© 2019 Wolters Kluwer Health, Inc. All rights reserved. Objective: The aim of tis study was to develop and externally validate the first evidence-based guidelines on minimally invasive pancreas resection (MIPR) before and during the International Evidence-based Guidelines on Minimally Invasive Pancreas Resection (IG-MIPR) meeting in Miami (March 2019). Summary Background Data: MIPR has seen rapid development in the past decade. Promising outcomes have been reported by early adopters from high-volume centers. Subsequently, multicenter series as well as randomized controlled trials were reported; however, guidelines for clinical practice were lacking. Methods: The Scottisch Intercollegiate Guidelines Network (SIGN) methodology was used, incorporating these 4 items: systematic reviews using PubMed, Embase, and Cochrane databases to answer clinical questions, whenever possible in PICO style, the GRADE approach for assessment of the quality of evidence, the Delphi method for establishing consensus on the developed recommendations, and the AGREE-II instrument for the assessment of guideline quality and external validation. The current guidelines are cosponsored by the International Hepato-Pancreato-Biliary Association, the Americas Hepato-Pancreato-Biliary Association, the Asian-Pacific Hepato-Pancreato-Biliary Association, the European-African Hepato-Pancreato-Biliary Association, the European Association for Endoscopic Surgery, Pancreas Club, the Society of American gastrointestinal and Endoscopic Surgery, and the Society for Surgery of the Alimentary. Results: After screening 16,069 titles, 694 studies were reviewed, and 291 were included. The final 28 recommendations covered 6 topics; laparoscopic and robotic distal pancreatectomy, central pancreatectomy, pancreatoduodenectomy, as well as patient selection, training, learning curve, and minimal annual center volume required to obtain optimal outcomes and patient safety. Conclusion: These IG-MIPR using SIGN methodology give guidance to surgeons, hospital administrators, patients, and medical societies on the use and outcome of MIPR as well as the approach to be taken regarding this challenging type of surgery

Is port site resection necessary in the surgical management of gallbladder cancer?

BACKGROUND: In selected patients with incidental gallbladder carcinoma (GBCA) diagnosed after laparoscopic cholecystectomy (LC), definitive resection is warranted. Port site excision has been advocated but remains controversial. METHODS: Patients with GBCA were identified through institutional/departmental databases. The subset of patients with incidental tumors identified after LC and submitted to definitive surgical therapy were selected. Those subjected to port site resection were compared with patients who underwent resection without port site removal and analyzed for differences in recurrence patterns and survival. RESULTS: From 1992 to 2009, 113 patients with incidental GBCA presented for definitive resection after LC; 69 patients had port site resection and 44 did not. In the resected port site group, depth of tumor invasion was T1b = 6, T2 = 35, T3 = 28, and 13 (19%) had port site metastases. Port site disease was seen only in patients with T2 or T3 tumors and correlated with the development of peritoneal metastases (P = 0.01). Median survival of patients with T2/T3 tumors without port site metastases was 42 months compared to 17 months in patients with port site disease (P = 0.005). When only R0 resected patients were compared and adjusted for T and N stage, port site resection was not associated with overall survival (P = 0.23) or recurrence-free survival (P = 0.69). CONCLUSIONS: In patients with incidental GBCA, port site metastases were associated with peritoneal disease and decreased survival. Port site resection was not associated with improved survival or disease recurrence and should not be considered mandatory during definitive surgical treatment

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 \u3c .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