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Can one extra stitch in pancreatic surgery get patients eating again sooner?

NCT ID NCT05709197

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether adding a Braun anastomosis, an extra connection between two parts of the small intestine, during standard pancreatic surgery helps prevent delayed gastric emptying. Delayed gastric emptying is a common complication where the stomach is slow to empty food, keeping patients from eating normally after surgery. The study enrolls adults undergoing an open pancreatic head resection, also known as a Whipple procedure, and randomly assigns them to receive either the standard reconstruction alone or with the extra Braun anastomosis. Researchers will compare how often delayed gastric emptying occurs in each group to see if the added step makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Braun anastomosis, an extra surgical connection between two loops of the small intestine added during pancreatic surgery
What this could lead to
If it works, this extra surgical step could become a standard part of pancreatic surgery, helping patients recover faster and leave the hospital sooner after a Whipple procedure.
What could go wrong
The trial is still testing the idea, and the extra connection may not reduce delayed gastric emptying. Surgery carries risks like bleeding, infection, or leakage at the new connection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

256 people

The number who actually took part.

Started

Apr 2023

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastroparesis malignant pancreatic neoplasm pancreas disorder pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Delayed gastric emptying Pancreatic cancer Pancreatic disease

Contacts and locations

Locations

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Catharina hospital

    Eindhoven, Netherlands

  • Erasmus MC

    Rotterdam, Netherlands

  • Groningen UMC

    Groningen, Netherlands

  • Isala hospital

    Zwolle, Netherlands

  • LUMC

    Leiden, Netherlands

  • Maastricht UMC+

    Maastricht, Netherlands

  • Medical center Leeuwarden

    Leeuwarden, Netherlands

  • Medical spectrum Twente

    Enschede, Netherlands

  • OLVG

    Amsterdam, Netherlands

  • Radboud UMC

    Nijmegen, Netherlands

  • St Antonius hospital

    Nieuwegein, Netherlands

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