Actively Recruiting
Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-27
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase II open, prospective study across 14 French centers to evaluate preoperative radiotherapy aimed at preventing postoperative pancreatic fistula in patients undergoing pancreaticoduodenectomy. This study focuses on patients aged 45 and older who are candidates for this surgery and have specific pancreatic duct and body mass index characteristics. The trial is sponsored by Assistance Publique - Hôpitaux de Paris and aims to assess the number of patients without significant pancreatic fistula within 90 days after surgery. Participants will receive a total dose of 20 Gy of stereotactic radiotherapy, delivered in two fractions of 10 Gy one day apart, targeting the pancreatic isthmus where the future anastomosis will be made. The treatment is administered before surgery, with key visits including a screening visit, radiation oncologist consultations, preoperative simulation, and radiotherapy delivery followed by pancreaticoduodenectomy approximately 10 weeks later. Postoperative follow-up visits occur at 30 days, 90 days, and six months after surgery to monitor recovery and any late effects from radiotherapy. Throughout the study, patients will undergo various assessments including imaging to validate treatment positioning, evaluation of pancreatic tissue hardness during surgery, pathological examination of resected tissue, and monitoring for surgical complications and pancreatic function. Researchers will also track radiation-induced complications, hospital stay duration, readmission rates, and overall safety. The total study participation extends to about six months post-surgery with careful medical follow-up by surgeons and radiation oncologists.
CONDITIONS
Brief Title
Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65 45 years old
- Candidate for pancreaticoduodenectomy by laparotomy
- Body mass index (BMI) 65 25kg/m2
- Diameter of main pancreatic duct (MPD) < 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas
- Affiliation to a social security system (AME excepted)
- Signed informed consent
You will not qualify if you...
- 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
- History of complicated peptic ulcer
- Patient treated for less than 4 weeks for an ulcer
- History of pancreatic surgery
- Ongoing pregnancy or breastfeeding or absence of birth control
- Patients with an active pathology or history that may interfere with the study or its results
- Patients with a history or suspicion of non-compliance with medical regimens or inability to complete the study
- Treatment with systemic corticosteroids (excluding inhaled corticosteroids)
- Participation in another interventional clinical study or exclusion period set after the study
- Protected persons under legal guardianship or conservatorship
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 days
Participants receive a dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, targeting the isthmus of the pancreas before surgery.
2 treatment sessions (in-person)
Duration - 1 day
Participants undergo pancreaticoduodenectomy surgery following preoperative radiotherapy.
1 surgical visit (in-person)
Duration - Up to 34 weeks
Participants are monitored for surgical complications, pancreatic function, radiation-induced complications, and overall recovery after surgery.
Multiple visits up to Week 34, including assessments at Weeks 9, 10, 14, 22, and 34
Trial Site Locations
Total: 1 location
1
Department of HPB Surgery, Hospital Pitié Salpétrière
Paris, France, 75013
Actively Recruiting
Research Team
S
Sébastien GAUJOUX, PU/PH
C
Charles DE PONTHAUD, PU/PH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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