Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Panc… (NCT05641233) | Clinical Trial Compass
UnknownPhase 1/2
Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
Netherlands33 participantsStarted 2020-12-01
Plain-language summary
The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (\>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.
Who can participate
Age range
18 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:
* Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.
* Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site).
* WHO-ECOG performance status 0,1 or 2.
* Ability to undergo stereotactic radiotherapy and surgery.
* Age ≥ 18 years.
* Good understanding of the oral and written patient information provided.
* Written informed consent.
Exclusion Criteria:
* Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.
* Patients with (a history of) chronic pancreatitis
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.
1This trial uses preoperative radiotherapy specifically to try to make the pancreas tissue firmer before surgery — is that approach something that could apply to my situation, and what does my doctor currently think my personal risk of a postoperative pancreatic fistula actually is?
2Since this is a Phase 1/2 trial, the main goal is still figuring out whether this preoperative radiation approach is safe — what is my doctor's honest assessment of the known versus unknown risks of adding radiation before my pancreatoduodenectomy, given that serious complications (Grade 3, 4, or 5) are what they're actively monitoring?
3The trial lists the recruitment status as unknown — is this study still actively enrolling patients, and if not, are there other similar trials or institutional protocols my doctor is aware of that use a comparable approach?
4The trial is measuring pancreas 'hardness' using something called a Durometer — can my doctor explain why a softer pancreas texture increases fistula risk, and based on imaging or other findings, does my pancreas fall into a category where this kind of intervention might even be relevant?
5Would my doctor recommend considering standard surgical management of fistula risk first — such as specific surgical techniques or drainage strategies — before pursuing an experimental preoperative radiation approach in a Phase 1/2 trial?
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
Safety - CTCAE grade 3-4-5 complications related to the intervention
Timeframe: Up to 30 days after surgery
2
Hardness of pancreas texture, determined by Durometer measurement
Timeframe: Histopathological assesment of tissue after surgery