Phase 2 Study of Preoperative Radiotherapy to Prevent Pancreatic Fistula After Pancreaticoduodenectomy Surgery

What this Trial Is About

Researchers are conducting a phase II open, prospective study across 14 French centers to evaluate preoperative radiotherapy aimed at preventing postoperative pancreatic fistula in patients undergoing pancreaticoduodenectomy. This study focuses on patients aged 45 and older who are candidates for this surgery and have specific pancreatic duct and body mass index characteristics. The trial is sponsored by Assistance Publique - Hpitaux de Paris and aims to assess the number of patients without significant pancreatic fistula within 90 days after surgery. Participants will receive a total dose of 20 Gy of stereotactic radiotherapy, delivered in two fractions of 10 Gy one day apart, targeting the pancreatic isthmus where the future anastomosis will be made. The treatment is administered before surgery, with key visits including a screening visit, radiation oncologist consultations, preoperative simulation, and radiotherapy delivery followed by pancreaticoduodenectomy approximately 10 weeks later. Postoperative follow-up visits occur at 30 days, 90 days, and six months after surgery to monitor recovery and any late effects from radiotherapy. Throughout the study, patients will undergo various assessments including imaging to validate treatment positioning, evaluation of pancreatic tissue hardness during surgery, pathological examination of resected tissue, and monitoring for surgical complications and pancreatic function. Researchers will also track radiation-induced complications, hospital stay duration, readmission rates, and overall safety. The total study participation extends to about six months post-surgery with careful medical follow-up by surgeons and radiation oncologists.

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