Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent (FRENCH24 ANIS)

NCT06123169 Phase 3 NOT_YET_RECRUITING

The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities, following pancreaticoduodenectomy in patients with preoperative biliary stent, to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)

Details

Lead sponsor	University Hospital, Rouen
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	326
Start date	2026-04
Completion	2028-07

Conditions

• Pancreaticoduodenectomy
• Antibiotherapy

Interventions

• Antibioprophylaxis (Piperacillin-tazobactam)
• 5 days Antibiotherapy (Piperacillin-tazobactam)

Primary outcomes

• presence of an organ/space SSI — 90 days after the surgery
  The primary End Point is the presence of an organ/space SSI determined according to the Centers for Disease Control and Prevention's national nosocomial infections surveillance system. Organ/space SSIs include postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.