Short preoperative stereotactic radiotherapy to prevent pancreatic leaks after Whipple surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, multicenter Phase 2 trial conducted across 14 French hepatopancreatobiliary surgery centers with associated radiation oncology departments. Eligible patients are adults planned for pancreaticoduodenectomy by laparotomy with BMI ≥25 and a main pancreatic duct <3 mm at the planned transection site, excluding those with pancreatic cancer, chronic pancreatitis, prior abdominal radiotherapy, or planned neoadjuvant therapy. The intervention is stereotactic preoperative radiotherapy delivering 20 Gy in two 10 Gy fractions (one-day gap) with imaging checks (CBCT with contrast or MRI) to verify target positioning before treatment. Surgery follows the radiotherapy per local practice and outcomes will focus on postoperative pancreatic fistula rates and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of HPB Surgery, Hospital Pitié Salpétrière
  Paris, France Recruiting

Study contacts

• Study coordinator: Sébastien GAUJOUX, PU/PH
• Email: sebastien.gaujoux@aphp.fr
• Phone: +33184827972

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Predicting pancreatic fistula after pancreaticoduodenectomy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.