Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative … (NCT07370987) | Clinical Trial Compass
RecruitingPhase 2
Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial
France50 participantsStarted 2026-02
Plain-language summary
Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments.
Implementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.
* Inclusion visit at the first surgical consultation (W-3 to D1) (V0) The inclusion visit will be done by the surgeon within 3 weeks before the first radiation oncologist visit
* D1 (V1): first radiation oncologist visit
* W2 (+/- 3D) and W4 (+/- 3D) (V2 et V3): Preoperative simulation process and treatment delivery
* A first visit at W+2 (+/- 3 D) will be mandatory to validate the positioning of the target volume by CBCT with IV constrast or MRI
* Then to start of the administration of radiotherapy at W+4 (+/- 3 D): Radiotherapy with 20 Gy, in 2 fraction of 10Gy with a one-day gap, so over a total period of 3
W9 ( +/- 1W) (V4): post-radiotherapy follow-up
\- Preoperative visit Day-1 before PD (V5)
W10 (+/- 1W) (V6):
* Pancreaticoduodenectomy and post operative hospitalisation W14 (+/- 1W) (V7): follow up with surgeon (30 days after pancreaticoduodenectomy)
* W22 (+/-1W) (V8): follow up with surgeon (90 days after pancreaticoduodenectomy)
* W34 (+/-1W) (V9): Last study visit (radiation oncologist) (6 months after pancreaticoduodenectomy) Medical follow-up by radiation oncologist at 6 months after surgery to assess the occurrence of potential late toxicities due to radiotherapy
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hist…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF)