NCT05709197

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Disease
• Pancreatic Cancer
• Delayed Gastric Emptying

Interventions

Type	Name	Description
PROCEDURE	Braun anastomosis	Participants will undergo open pancreatoduodenectomy (PD). The reconstruction technique will not be standardized. In addition to the reconstruction technique used, a side-to-side anastomosis will be created between the afferent and efferent jejunal limbs of the gastrojejunostomy (GJ) at 20 cm distance from the GJ. The anastomosis will be hand-sewn with monofilament PDS 3-0 one-layer running suture.
PROCEDURE	Standard Child reconstruction	Participants will undergo open pancreatoduodenectomy (PD). The reconstruction technique will not be standardized. The surgeon is able to perform the PD as normally would be done (antecolic, retrocolic, pylorus-preserving or with distal gastric resecting).

Timeline

• Start date: 2023-04-17
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-02-02
• Last updated: 2024-04-11

Locations

12 sites across 1 country: Netherlands