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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorAssistance Publique - Hôpitaux de Paris

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 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

Eligibility criteria

Qualifiers

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)

Disqualifiers

Surgery indication : Chronic pancreatitis

Surgery indication : Pancreatic ductal adenocarcinoma

History of syndromic or hereditary pancreatic tumor

Contraindication to pancreaticoduodenectomy

Trial design

Treatments tested in this trial

  • Stereotactic radiotherapy / pancreaticoduodenectomy

Treatment groups

50 Participants
are divided into 1 treatment group