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Pancreatic DiseaseREMBRANDTNCT05709197

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

A study testing Braun anastomosis and Standard Child reconstruction in people with Pancreatic Disease and Pancreatic Cancer, run by Radboud University Medical Center at 12 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Braun anastomosis and Standard Child reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
12 sitesNetherlands
Study dates
17 Apr 2023to 24 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

12 sites in 1 country.

12 sites in 1 country

Netherlands12 sites

  • Amsterdam UMC

    Amsterdam

  • OLVG

    Amsterdam

  • Catharina hospital

    Eindhoven

  • Medical spectrum Twente

    Enschede

  • Groningen UMC

    Groningen

  • Medical center Leeuwarden

    Leeuwarden

  • LUMC

    Leiden

  • Maastricht UMC+

    Maastricht

  • St Antonius hospital

    Nieuwegein

  • Radboud UMC

    Nijmegen

  • Erasmus MC

    Rotterdam

  • Isala hospital

    Zwolle

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Braun anastomosis, Standard Child reconstruction
Keywords
Randomized controlled trial, Prospective studies, Braun anastomosis, Braun enteroenterostomy
Medical subject headings
Pancreatic Diseases, Pancreatic Neoplasms, Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Braun anastomosisProcedure or surgery

    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.

  • Standard Child reconstructionProcedure or surgery

    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).

Study groups in NCT05709197
Study groupRoleWhat they receive
Braun anastomosisExperimentalOpen pancreatoduodenectomy with Braun enteroenterostomy
Receives: Procedure: Braun anastomosis
Standard Child reconstructionOtherOpen pancreatoduodenectomy only
Receives: Procedure: Standard Child reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delayed gastric emptying (DGE)

    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.

    Measured: During hospitalization

Secondary outcomes (10)

  1. Pancreatic fistula (POPF)

    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.

    Measured: During hospitalization

  2. Anastomotic leak

    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.

    Measured: During hospitalization

  3. Postoperative complications: incidence and severity

    Scored according to the modified Clavien-Dindo classification for surgical complications. Grade III and higher are considered clinically relevant in this study.

    Measured: During hospitalization

  4. Number of days participants were hospitalized

    The time period in days between hospital admission and discharge from the hospital.

    Measured: During hospitalization

  5. Number of participants with in-hospital mortality

    Any death during hospital admission.

    Measured: During hospitalization

  6. 30-day mortality

    Any death occurring 30 days after pancreatoduodenectomy.

    Measured: 30 days

  7. Quality of life (QoL) based on five dimensions

    The EQ-5D-5L standardized questionnaire will be used.

    Measured: Change from baseline at 1 week, at 2 weeks, and 3 months

  8. Participants perceived disease and treatment related quality of life

    The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/PAN26 standardized quality of life questionnaires will be used.

    Measured: Change from baseline at 2 weeks, 3 months, and 12 months

  9. Quality of recovery

    The QoR-15 standardized questionnaire will be used.

    Measured: Change from baseline at 1 week, at 2 weeks, and 3 months

  10. Functional outcome at 12 months

    Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome").

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start17 Apr 2023
  3. Primary completion24 Jul 2026
  4. Study completion24 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709197
Sponsor's protocol ID
NL 82918.091.22
Acronym
REMBRANDT
Status last verified
Aug 2026
First submitted
24 Jan 2023
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Strijbos BTM, Hopstaken JS, Endo C, de Vries M, Atsma F, Adang E, van der Wees P, Besselink MGH, van Santvoort H, den Dulk M, Groot Koerkamp B, Mieog JSD, Zeverijn S, van Laarhoven CJHM, Stommel MWJ; Dutch Pancreatic Cancer Group. 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. Trials. 2025 Oct 2;26(1):387. doi: 10.1186/s13063-025-09051-x.

    PubMed 41039614

Questions about this trial

What is this clinical trial studying?

A study testing Braun anastomosis and Standard Child reconstruction in people with Pancreatic Disease and Pancreatic Cancer, run by Radboud University Medical Center at 12 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delayed gastric emptying (DGE) (time frame: During hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709197, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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