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

August 31, 2026 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • OLVG
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Enschede, Netherlands
        • Medical Spectrum Twente
      • Groningen, Netherlands
        • Groningen UMC
      • Leeuwarden, Netherlands
        • Medical center Leeuwarden
      • Leiden, Netherlands
        • LUMC
      • Maastricht, Netherlands
        • Maastricht UMC+
      • Nieuwegein, Netherlands
        • St Antonius hospital
      • Nijmegen, Netherlands
        • Radboud UMC
      • Rotterdam, Netherlands
        • Erasmus MC
      • Zwolle, Netherlands
        • Isala Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Braun anastomosis
Open pancreatoduodenectomy with Braun enteroenterostomy
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.
Other: Standard Child reconstruction
Open pancreatoduodenectomy only
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed gastric emptying (DGE)
Time Frame: During hospitalization
DGE is defined by the need for maintenance of the nasogastric tube (NGT), need for reinsertion of NGT for persistent vomiting after postoperative day (POD) 7, or inability to tolerate a solid diet.
During hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic fistula (POPF)
Time Frame: During hospitalization
Any measurable volume of drain output with an amylase level of more than 3 times the upper limit of normal serum amylase and clinically relevant condition or development of the patient directly related to the POPF.
During hospitalization
Anastomotic leak
Time Frame: During hospitalization

Anastomotic leaks of the hepatojejunostomy (HJ) or Braun enteroenterostomy (BE).

Anastomotic leaks of the HJ manifest as bile leakage. This is defined as "fluid with an increased bilirubin concentration in the abdominal drain or in the intra-abdominal fluid on or after postoperative day 3, or as the need for radiologic intervention because of biliary collections or relaparotomy resulting from bile peritonitis. Increased bilirubin in the drain is defined as bilirubin concentration more than 3 times greater than the serum bilirubin concentration.

An anastomotic leak of the BE is present when an abdominal CT with contrast shows leakage of contrast from the BE or when during relaparotomy dehiscence of the BE is apparent.
During hospitalization
Postoperative complications: incidence and severity
Time Frame: During hospitalization
Scored according to the modified Clavien-Dindo classification for surgical complications. Grade III and higher are considered clinically relevant in this study.
During hospitalization
30-day mortality
Time Frame: 30 days
Any death occurring 30 days after pancreatoduodenectomy.
30 days
Quality of life (QoL) based on five dimensions
Time Frame: Change from baseline at 1 week, at 2 weeks, and 3 months
The EQ-5D-5L standardized questionnaire will be used.
Change from baseline at 1 week, at 2 weeks, and 3 months
Participants perceived disease and treatment related quality of life
Time Frame: Change from baseline at 2 weeks, 3 months, and 12 months
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/PAN26 standardized quality of life questionnaires will be used.
Change from baseline at 2 weeks, 3 months, and 12 months
Quality of recovery
Time Frame: Change from baseline at 1 week, at 2 weeks, and 3 months
The QoR-15 standardized questionnaire will be used.
Change from baseline at 1 week, at 2 weeks, and 3 months
Functional outcome at 12 months
Time Frame: 12 months
Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome").
12 months
Number of days participants were hospitalized
Time Frame: During hospitalization
The time period in days between hospital admission and discharge from the hospital.
During hospitalization
Number of participants with in-hospital mortality
Time Frame: During hospitalization
Any death during hospital admission.
During hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Rising Tide Foundation

Investigators

  • Principal Investigator: Martijn WJ Stommel, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

July 24, 2026

Study Completion (Actual)

July 24, 2026

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL 82918.091.22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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