NCT06123169

Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

Despite cumulative efforts in surgery and perioperative management, the morbi-mortality rates of pancreatoduodenectomy (PD) remain high. The most frequent complications were sepsis and infectious complications 44%, hemorrhagic complications 36.6%, pulmonary complications 35.2%, shock 29.8% and pancreatic fistula 27.9%. PD is a technically complex procedure with substantial associated morbidity and mortality. Infectious complications have been reported to occur in as many as 30% of patients following open PD. Biliary colonization that arises from preoperative procedures for biliary drainage closely predicts infectious complications following PD. Besides biliary intervention, nutritional reserve and biliary or pancreatic anastomotic leaks are common factors linked to developing infectious complications following PD. D'Angelica et al. Recently demonstrated the superiority of Piperacillin-tazobactam compared with cefoxitin as antimicrobial prophylaxis for PD: a randomized clinical trial in JAMA, with a significant reduction of postoperative SSI rate. One of the main risk factors for infectious complications and especially surgical site infections, but also post-operative pancreatic fistula is bacteriobilia, defined by the bile contamination by microorganism(s) related to preoperative biliary drainage. A significant decrease in all-type SSI and organ-space SSI with Broad spectrum antibiotics was observed after open PD, as reported by Kone et al. or De Grandi et al. According to Kone et al. on subgroup analysis, only patients with preoperative biliary stents and/ or jaundice (61% of PD patients) had an association between Broad-abx and decreased SSI. Numbered of surgeons modified their antibiotic usage in this setting of preoperative biliary drainage, as we also observed in France, where more than 50% prescribed a broad spectrum antibiotherapy intraoperatively only (antibioprophylaxis) or for 3 to 5 days. The aim of this study is to determine whether a prophylactic treatment used only during surgery, or for 5 days with this treatment, in the clinical context of PD after biliary drainage, is effective in reducing surgical complications, particularly infectious ones. Such results could reduce the need for prolonged anti-infectious treatments and reoperations (surgical and radiological). Hospital stays could also be shortened, with a positive impact on your quality of life.

Conditions

• Pancreaticoduodenectomy
• Antibiotherapy

Interventions

Type	Name	Description
DRUG	Antibioprophylaxis (Piperacillin-tazobactam)	antibiotic prophylaxis during surgery
DRUG	5 days Antibiotherapy (Piperacillin-tazobactam)	5 days Antibiotherapy from surgery

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2023-11-08
• Last updated: 2026-02-06