Short preoperative stereotactic radiotherapy to prevent pancreatic leaks after Whipple surgery
Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial
This trial will test whether a short course of stereotactic radiotherapy given before a Whipple operation can reduce the chance of a pancreatic leak (fistula) in adults having a pancreaticoduodenectomy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Paris) |
| Trial ID | NCT07370987 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 or older with BMI ≥25 who are scheduled for pancreaticoduodenectomy by open surgery and have a main pancreatic duct diameter under 3 mm at the planned transection site, with no contraindication to radiotherapy or major exclusions listed in the protocol.
Not a fit: Patients with pancreatic ductal adenocarcinoma, chronic pancreatitis, prior abdominal radiotherapy, planned neoadjuvant chemotherapy or radiotherapy, planned multivisceral resections, or other contraindications to surgery or radiotherapy are not expected to benefit and are excluded.
Why it matters
Potential benefit: If successful, this approach could lower the rate and severity of postoperative pancreatic fistula, reducing complications, length of stay, and need for additional interventions.
How similar studies have performed: This preoperative radiotherapy approach is relatively novel with limited evidence from small or retrospective reports and no large definitive trials demonstrating effectiveness to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.