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

Radboud University Medical Center

Status: Enrolling

Conditions: Delayed Gastric Emptying; Pancreatic Disease; Pancreatic Cancer

Treatments: Procedure: Braun anastomosis; Procedure: Standard Child reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05709197

NL 82918.091.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing open pancreatoduodenectomy
• Provided informed consent
• Age over 18 years

Exclusion criteria

• Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires in Dutch hospitals
• Previous bariatric surgery (such as Roux-en-Y gastric bypass, gastric sleeve)
• Pregnancy
• Bowel motility disorders
• Minimally invasive pancreatoduodenectomy
• Gastric outlet syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Braun anastomosis

Experimental group

Description:

Open pancreatoduodenectomy with Braun enteroenterostomy

Treatment:

Procedure: Braun anastomosis

Standard Child reconstruction

Other group

Description:

Open pancreatoduodenectomy only

Treatment:

Procedure: Standard Child reconstruction