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

Inclusion Criteria3

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

Exclusion Criteria6

  • 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

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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