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

Exclusion Criteria

• •Surgery indication : Chronic pancreatitis
• •Surgery indication : Pancreatic ductal adenocarcinoma
• •History of syndromic or hereditary pancreatic tumor
• •Contraindication to pancreaticoduodenectomy
• •Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy
• •Planned external drainage of the main pancreatic duct at the end of the surgery
• •Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy
• •History of chronic hepatitis (F3) or cirrhosis (F4)
• •Contraindication to radiotherapy
• •Previous history of abdominal radiotherapy
• •Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus)
• •History of complicated peptic ulcer
• •Patient treated for less than 4 weeks for an ulcer
• •History of pancreatic surgery
• •Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control
• •Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator
• •Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study
• •Treatment with systemic corticosteroids (excluding inhaled corticosteroids)
• •Participation in another interventional clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study
• •Protected persons under legal guardianship or conservatorship