Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial
Recruiting
Phase 2
Interventional Study
Pancreatic Fistula
Pancreaticoduodenectomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 50 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 surgic…
Trial Locations
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Eligibility 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…
Contacts