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Radiation before pancreatic surgery may prevent dangerous leaks

NCT ID NCT07370987

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether giving a short course of radiation before pancreatic surgery can prevent a common and serious complication called pancreatic fistula. About 50 patients with a high risk of this complication will receive two doses of radiation before their surgery. Researchers will then track how many patients avoid a fistula within 90 days after the operation.

What this could mean

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

Active substance
stereotactic radiotherapy
What this could lead to
If it works, this could reduce a serious complication after pancreatic surgery, making recovery safer for patients.
What could go wrong
This is a small, early-phase trial with only 50 participants and no comparison group, so results may not be conclusive. Radiotherapy also carries risks like radiation toxicity.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

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

45 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: * Aged ≥ 45 years old * Candidate for pancreaticoduodenectomy by laparotomy * Body mass index (BMI) ≥ 25kg/m2 * Diameter of main pancreatic duct (MPD) \< 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area) * Affiliation to a social security system (AME excepted) * Signed informed consent Exclusion Criteria: * Surgery indication : Chronic pancreatitis * Surgery indication : Pancreatic ductal adenocarcinoma * History of syndromic or hereditary pancreatic tumor * Contraindication to pancreaticoduodenectomy * Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy * Planned external drainage of the main pancreatic duct at the end of the surgery * Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy * History of chronic hepatitis (F3) or cirrhosis (F4) * Contraindication to radiotherapy * Previous history of abdominal radiotherapy * Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus) * History of complicated peptic ulcer * Patient treated for less than 4 weeks for an ulcer * History of pancreatic surgery * Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control * Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator * Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study * Treatment with systemic corticosteroids (excluding inhaled corticosteroids) * Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study * Protected persons under legal guardianship or conservatorship

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Conditions

The condition(s) this trial relates to.

Pancreatic Fistula

As listed by the trial registrant

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

Pancreatic fistula Pancreaticoduodenectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of HPB Surgery, Hospital Pitié Salpétrière

    RECRUITING

    Paris, 75013, France

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