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

NCT05709197 | Recruiting

• 1 other identifier: NL 82918.091.22
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 12

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.

Conditions

Pancreatic Disease; Pancreatic Cancer; Delayed Gastric Emptying

Keywords

Randomized controlled trial; Prospective studies; Braun anastomosis; Braun enteroenterostomy

Outcome Measures

Primary Outcomes (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.

  During hospitalization

Secondary Outcomes (10)

• Pancreatic fistula (POPF)

  During hospitalization

• Anastomotic leak

  During hospitalization

• Postoperative complications: incidence and severity

  During hospitalization

• Number of days participants were hospitalized

  During hospitalization

• Number of participants with in-hospital mortality

  During hospitalization

Study Arms (2)

Braun anastomosis

EXPERIMENTAL

Open pancreatoduodenectomy with Braun enteroenterostomy

Procedure: Braun anastomosis

Standard Child reconstruction

OTHER

Open pancreatoduodenectomy only

Procedure: Standard Child reconstruction

Interventions

Braun anastomosis PROCEDURE

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.

Braun anastomosis

Standard Child reconstruction PROCEDURE

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).

Standard Child reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Rising Tide Foundation: collaborator

Study Sites (12)

Amsterdam UMC

Amsterdam, Netherlands

NOT YET RECRUITING

OLVG

Amsterdam, Netherlands

NOT YET RECRUITING

Catharina hospital

Eindhoven, Netherlands

NOT YET RECRUITING

Medical spectrum Twente

Enschede, Netherlands

NOT YET RECRUITING

Groningen UMC

Groningen, Netherlands

NOT YET RECRUITING

Medical center Leeuwarden

Leeuwarden, Netherlands

NOT YET RECRUITING

LUMC

Leiden, Netherlands

NOT YET RECRUITING

Maastricht UMC+

Maastricht, Netherlands

NOT YET RECRUITING

St Antonius hospital

Nieuwegein, Netherlands

NOT YET RECRUITING

Radboud UMC

Nijmegen, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

NOT YET RECRUITING

Isala hospital

Zwolle, Netherlands

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 41039614 DERIVED

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Neoplasms; Gastroparesis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martijn WJ Stommel, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo TM Strijbos, MD

CONTACT

0031243668086; bo.strijbos@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded considering their treatment allocation. The house officer, ward nurses and data managers who extract data concerning the primary and secondary endpoint will be blinded for the allocation as well. For this reason, this will be a patient- and observer blinded RCT.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: April 17, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

NL (12)