Patients with preoperative biliary stent treated by pancreaticoduodenectomy MedDRA version: 20.0 Level: LLT Classification code 10073866 Term: Tumor of hepatopancreatic ampulla System Organ Class: 100000004864
Conditions
Interventions
Trade Name: PIPERACILLINE/TAZOBACTAM PANPHARMA 4 g/500 mg, poudre pour solution pour perfusion
Product Name: PIPERACILLINE/TAZOBACTAM PANPHARMA 4 g/500 mg, poudre pour solution pour perfusion
Pharmace
Sponsors
CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion 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 (health insurance) category • Person of full age having read and understood the information letter and signed the consent form • Women of childbearing potential with effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) since 1 month and an negative blood pregnancy test by ?-HCG at inclusion, during the duration of the study. • Women surgically sterile (absence of ovaries and/or uterus) • Postmenopausal women : confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 226 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection and LEVOFLOXACINE ARROW 5mg/ml solution for infusion in bag + METRONIDAZOLE B BRAUN 0,5%, solution for infusion* • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI);Secondary Objective: The secondary objectives, with complications/morbidity assessed at 90 days, are as follows: • Evaluation of the overall morbidity associated with the different treatment modes by recording surgical complications • Evaluation of antibiotic resistance profiles and their impact on post-operative complications • Assessment of the pathogenicity of bacteriological and fungal co-contamination • Evaluation of the impact of complications after bile drainage and neoadjuvant treatment on the bacteriological and fungal profile of biliculture • Cost effectiveness analysis ;Primary end point(s): The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.;Timepoint(s) of evaluation of this end point: during the 5 post-operative days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study’s secondary criteria are as follows: • Infectious complications at post-operative day 90 Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90 Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria Readmission rates at post-operative day 90 Duration of hospitalization • Correlation between post-operative bacteriological samples and intraoperative bile samples • Bacteriological resistance profiles Incidence of fungal contamination • Correlation between bacteriological and fungal contaminations • Incremental cost per infectious complications avoided ;Timepoint(s) of evaluation of this end point: during the 5 post-operative days | — |
Countries
France
Contacts
Public ContactJulie RONDEAUX
CHU de Rouen
Outcome results
None listed