NCT07370987

Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial

Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy: a Phase 2 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Fistula
• Pancreaticoduodenectomy

Interventions

Type	Name	Description
OTHER	Stereotactic radiotherapy / pancreaticoduodenectomy	A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-08-01
• Completion: 2027-11-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: France