Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen
About this trial
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)
Eligibility criteria
Qualifiers
Planned pancreaticoduodenectomy for periampullary neoplasms
Endoscopic or radiological pre-operative biliary drainage
Age ≥ 18 years old
Patient able to comply with the study protocol, in the investigator's judgment
Disqualifiers
Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC
Patients allergic to beta-lactam antibiotics
Others pancreatic resection
Absence of preoperative biliary drainage
Trial design
Treatments tested in this trial
- Antibioprophylaxis (Piperacillin-tazobactam)
- 5 days Antibiotherapy (Piperacillin-tazobactam)
Treatment groups
326 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov