ArticleTrials2025
The effectiveness of adding Braun anastomosis to standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): study protocol for a multicentre randomised-controlled trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05709197 (The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy), which is not on this map. Not yet cited in PubMed.
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The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial
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16 authors.
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Abstract
backgroundPancreatoduodenectomy (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.
methodsThe 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 registrationClinicalTrials.gov NCT05709197. Registered on January 24, 2023.
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