Evaluating the addition of Braun anastomosis in pancreatic surgery
The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial
This study is testing if adding a Braun anastomosis to standard surgery for pancreatic cancer can help patients recover better and avoid problems with delayed stomach emptying.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 12 sites (Amsterdam and 11 other locations) |
| Trial ID | NCT05709197 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of adding a Braun anastomosis to standard reconstruction after pancreatoduodenectomy to reduce the incidence of delayed gastric emptying (DGE). It is a multicenter, patient and observer-blinded, registry-based randomized controlled trial involving patients undergoing open pancreatoduodenectomy. The study will compare outcomes between those receiving the Braun anastomosis and those receiving standard Child reconstruction, focusing on postoperative complications and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for open pancreatoduodenectomy.
Not a fit: Patients with previous bariatric surgery, bowel motility disorders, or those undergoing minimally invasive procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of delayed gastric emptying and related complications in patients undergoing pancreatic surgery.
How similar studies have performed: Other studies have explored similar surgical modifications, but the specific effectiveness of Braun anastomosis in this context remains to be fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam and 11 other locations
- 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)
Study contacts
- Principal investigator: Martijn WJ Stommel, MD, PhD — Radboud University Medical Center
- Study coordinator: Bo TM Strijbos, MD
- Email: bo.strijbos@radboudumc.nl
- Phone: 0031243668086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.