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

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

• 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

• Patient affiliated with, or beneficiary of a social security (national health insurance) category

• Person of full age having read and understood the information letter and signed the consent form

• Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) with hightly effective contraception (Cf. CTFG) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month and during the duration of the study and a negative blood pregnancy test by beta-HCG at inclusion.

• Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

• Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Exclusion Criteria:

• 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

• Surgical or anaesthesiological contra-indications:

• non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT

• major non-controlled infection

• severe liver failure

• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent

• Any significant disease, which, in the investigator's opinion, would exclude the patient from the study

• Pregnant or parturient or breastfeeding woman or absence of contraceptionn

• Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision

• Simultaneous participation in another interventional research with the same primary endpoint.