Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial

IntroductionPartial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach-preserving PD variants exist: pylorus preservation PD (ppPD) or pylorus resection PD (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, for example, adjuvant chemotherapy. Evidence is lacking to assess, which variant of PD entails fewer postoperative DGE.Methods and analysisThe protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery. The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay and operation time. Complication rates and adverse events will be closely monitored.Ethics and disseminationThis protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-Universität, Munich (reference number 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (http://www.dgav.de/studoq/pylorespres/).Trial registration numberDRKS-ID: DRKS00018842.

Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPes): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial

Introduction Partial pancreatoduodenectomy (PD) is the treatment of choice for various benign and malignant tumours of the pancreatic head or the periampullary region. For reconstruction of the gastrointestinal passage, two stomach preserving PD variants exist: pylorus preservation (ppPD), or pylorus resection (prPD) with preservation of the stomach. In pancreatic surgery, delayed gastric emptying (DGE) remains a serious complication after PD with an incidence varying between 4.5% and 45%, potentially delaying hospital discharge or further treatment, e.g. adjuvant chemotherapy. Evidence is lacking to assess which variant of PD entails fewer postoperative DGE. Methods and analysis The protocol of a large-scale, multicentre, pragmatic, two-arm parallel-group, registry-based randomised controlled trial (rRCT) using a two-stage group-sequential design is presented. This patient-blind rRCT aims to demonstrate the superiority of prPD over ppPD with respect to the overall incidence of DGE within 30 days after index surgery in a German real-world setting. A total of 984 adults undergoing elective PD for any indication will be randomised in a 1:1 ratio. Patients will be recruited at about 30 hospitals being members of the StuDoQ|Pancreas registry established by the German Society of General and Visceral Surgery (DGAV). The postoperative follow-up for each patient will be 30 days. The primary analysis will follow an intention-to-treat approach and applies a binary logistic random intercepts model. Secondary perioperative outcomes include overall severe morbidity (Clavien-Dindo classification), blood loss, 30-day all-cause mortality, postoperative hospital stay, and operation time. Complication rates and adverse events will be closely monitored. Ethics and dissemination This protocol was approved by the leading ethics committee of the Medical Faculty of the Ludwig-Maximilians-University, Munich (reference no. 19-221). The results will be published in a peer-reviewed journal and presented at international conferences. Study findings will also be disseminated via the website (http://www.dgav.de/studoq/pylorespres/). Trial registration number DRKS-ID: DRKS00018842 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018842, prospectively registered on 24-Oct-2019)

The role of the surgical resection distance from the pylorus after laparoscopic sleeve gastrectomy: a prospective cohort study from an academic medical center in Egypt

Background Laparoscopic sleeve gastrectomy was recently described as an effective approach for the operative treatment of obesity, but the ideal procedure remains controversial. One of the most debated issues is the resection distance from the pylorus. We conducted this study to elucidate any potential differences in the short-term outcomes between 2 and 6 cm distance from the pylorus in laparoscopic sleeve gastrectomy. Methods A prospective observational cohort study in a selected cohort of 96 patients was conducted from January 2018 to March 2019 in morbidly obese patients who had laparoscopic sleeve gastrectomy performed at Suez Canal University Hospital. Outcome was expressed by excess weight loss percentage, resolution of comorbidities, improvement of quality of life, and incidence of complications after laparoscopic sleeve gastrectomy. The morbidly obese patients (body mass index [BMI] > 40 kg/m2 or > 35 kg/m2 with obesity-related comorbidities) in the study were divided into two equal groups: (1) Group 1 (48 patients) underwent laparoscopic sleeve gastrectomy with a 2 cm distance from the pylorus resection distance and (2) Group 2 (48 patients) underwent laparoscopic sleeve gastrectomy with a 6 cm distance from the pylorus resection distance. Body weight, BMI, bariatric quality of life, lipid profile, and comorbidities were evaluated pre- and post-operatively for a duration of 12 months. Results Statistically, no significant differences between the two study groups regarding the excess weight loss percentage, comorbidity resolution throughout the postoperative follow-up, enhancement of the quality of life score throughout the postoperative follow-up, or incidence of complications (25% in Group 1 versus 25% in Group 2, p > 0.05) were found. Conclusion Laparoscopic sleeve gastrectomy was an effective and safe management for morbid obesity and obesity-related comorbidities with significant short-term weight loss; it also improved weight-related quality of life and had an acceptable complication rate. The distance from the pylorus resection distance did not affect the short-term effects of laparoscopic sleeve gastrectomy regarding excess weight loss percentage, resolution of comorbidities, change in quality of life, or occurrence of complications.