Spots Global Cancer Trial Database for The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy

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Trial Identification

Brief Title: The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy

Official Title: The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial

Study ID: NCT05709197

Conditions

Pancreatic Disease

Pancreatic Cancer

Delayed Gastric Emptying

Interventions

Braun anastomosis

Standard Child reconstruction

Study Description

Brief Summary: The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.

Detailed Description: Rationale/hypothesis: The addition of Braun enteroenterostomy (BE) reduces the incidence of delayed gastric emptying (DGE) resulting in lower morbidity and healthcare costs after pancreatoduodenectomy. Objective: To assess the effectiveness of adding BE in reducing DGE in patients undergoing open pancreatoduodenectomy. Study design: A multicenter, patient and observer blinded, registry-based randomized controlled trial. Study population: Patients undergoing an open pancreatoduodenectomy for all indications. Intervention: Braun enteroenterostomy (BE), or Braun anastomosis, in addition to usual care. Usual care/comparison: Pancreatoduodenectomy with standard Child reconstruction. Main endpoints: 1. Incidence of DGE Grade B/C (according to International Study Group of Pancreatic Surgery (ISGPS) 2. Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to ISGPS), anastomotic leak, complications, hospital length of stay, functional outcome at 12 months, in-hospital mortality, 30-day mortality, healthcare costs. Sample size: 256 in total, 128 per arm Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients undergoing open pancreatoduodenectomy have an increased risk of postoperative complications such as DGE, POPF and anastomotic leak. The addition of BE, which is an anastomosis, could also result in a leak. However, this risk is diminishable compared to the risks of DGE and DGE related other complications like anastomotic leaks associated with standard pancreatoduodenectomy. Moreover, previous cohort studies involving BE do not describe an increased risk of adverse outcomes for BE.