RecruitingNot ApplicableNCT05709197

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

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


Sponsor

Radboud University Medical Center

Enrollment

256 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an extra connection in the intestine (called a Braun anastomosis) during standard pancreatic surgery (Whipple procedure) reduces complications like bile reflux and improves recovery outcomes. **You may be eligible if...** - You are 18 or older - You are scheduled for an open Whipple procedure (pancreatoduodenectomy) for a pancreatic condition - You are able to give informed consent **You may NOT be eligible if...** - You cannot adequately understand or complete Dutch-language questionnaires (for patients at Dutch hospitals) - You have previously had bariatric surgery such as gastric bypass - You are pregnant - You have a bowel motility disorder - You are having minimally invasive (laparoscopic/robotic) surgery instead of open surgery - You have a gastric outlet blockage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBraun 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.

PROCEDUREStandard 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).


Locations(12)

Amsterdam UMC

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Catharina hospital

Eindhoven, Netherlands

Medical spectrum Twente

Enschede, Netherlands

Groningen UMC

Groningen, Netherlands

Medical center Leeuwarden

Leeuwarden, Netherlands

LUMC

Leiden, Netherlands

Maastricht UMC+

Maastricht, Netherlands

St Antonius hospital

Nieuwegein, Netherlands

Radboud UMC

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Isala hospital

Zwolle, Netherlands

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NCT05709197


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