Abstract
BACKGROUND: Pancreatoduodenectomy (PD) is associated with a high risk of complications, such as delayed gastric emptying (DGE) (19-45%). Patients with DGE experience symptoms of nausea, vomiting, inability to tolerate solid food and prolonged dependence on a nasogastric tube (> 7 days), leading to extended hospital stay. A potential mean to reduce DGE is reconstruction after PD with addition of Braun's enteroenterostomy (BE), an anastomosis between the afferent and efferent jejunal limbs distal to the gastrojejunostomy (GJ). Previous prospective-cohort studies and few small randomised controlled studies demonstrated a beneficial effect of BE in reducing DGE. Aim of this study is to obtain robust evidence for the effectiveness of BE in reducing DGE in patients undergoing PD. METHODS: The REMBRANDT trial is a multicentre, patient-observer blinded, randomised controlled trial. Adult patients undergoing open PD are recruited in 12 participating centres. Primary outcome is the incidence of DGE. Secondary outcomes include postoperative complications, such as postoperative pancreatic fistula, anastomotic leakage and mortality. Additionally, the study will assess length of hospital stay, patient-reported outcomes, functional outcomes after 12 months and costs. Randomisation is performed intraoperatively (1:1) with stratification of groups by centre, with a sample size of 128 patients per arm. DISCUSSION: This trial is designed to evaluate the effectiveness of Braun anastomosis in reducing delayed gastric emptying after open pancreatoduodenectomy. Throughout the trial, semi-structured interviews will be conducted with surgeons in order to perform a barrier-facilitator analysis, allowing for successful implementation of BE if proven effective. TRIAL REGISTRATION: ClinicalTrials.gov NCT05709197. Registered on January 24, 2023.