Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent
FRENCH24 ANIS
2 other identifiers
interventional
326
0 countries
N/A
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 stent, to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
February 6, 2026
February 1, 2026
2.3 years
October 26, 2023
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
presence of an organ/space SSI
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.
90 days after the surgery
Secondary Outcomes (6)
Infectious complications at post-operative
day 90
Correlation between post-operative bacteriological samples and intraoperative bile samples
day 90
Bacteriological resistance profiles
day 90
Correlation between bacteriological and fungal contaminations
day 90
Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria
day 90
- +1 more secondary outcomes
Study Arms (2)
Broad spectrum antibioprophylaxis
ACTIVE COMPARATORAntibioprophylaxis with Piperacillin-tazobactam during DPC.
Broad spectrum antibiotherapy
EXPERIMENTAL5 days Antibiotherapy (Piperacillin-tazobactam) from surgery.
Interventions
antibiotic prophylaxis during surgery
5 days Antibiotherapy from surgery
Eligibility Criteria
You may qualify if:
- 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 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Schwarz L, Gillibert A, Rondeaux J, Lacroix E, Sa Cunha A, Joannes-Boyau O. Study protocol of the FRENCH24-ANIS study: postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stents-an intergroup FRENCH-ACHBT-SFAR prospective randomized controlled trial. BMC Surg. 2024 Aug 22;24(1):237. doi: 10.1186/s12893-024-02507-y.
PMID: 39169298DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2023
First Posted
November 8, 2023
Study Start
April 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share