Status:
NOT_YET_RECRUITING
Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent
Lead Sponsor:
University Hospital, Rouen
Conditions:
Pancreaticoduodenectomy
Antibiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 sten...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT06123169
Start Date
March 1 2024
End Date
June 1 2026
Last Update
November 8 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.