Piperacillin (as piperacillin sodium / piperacillin monohydrate) and Tazobactam (tazobactam sodium) for Periampullary neoplasm | Ampullary (hepatopancreatic ampulla) tumor

Inclusion criteria

• {"criterion_text":"- Planned pancreaticoduodenectomy for periampullary neoplasms"}
• {"criterion_text":"- Endoscopic or radiological pre-operative biliary drainage"}
• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- Patient able to comply with the study protocol, in the investigator’s judgment"}
• {"criterion_text":"- Patient affiliated with, or beneficiary of a social security (national health insurance) category"}
• {"criterion_text":"- Person of full age having read and understood the information letter and signed the consent form"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy."}
• {"criterion_text":"- 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

• {"criterion_text":"- Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC"}
• {"criterion_text":"- Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision"}
• {"criterion_text":"- Severe renal failure"}
• {"criterion_text":"- Simultaneous participation in another interventional research with the same primary endpoint."}
• {"criterion_text":"- Patients allergic to beta-lactam antibiotics"}
• {"criterion_text":"- Others pancreatic resection"}
• {"criterion_text":"- Absence of preoperative biliary drainage"}
• {"criterion_text":"- Surgical or anaesthesiological contra-indications: •\tnon-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 •\tmajor non-controlled infection •\tsevere liver failure"}
• {"criterion_text":"- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent"}
• {"criterion_text":"- Any significant disease, which, in the investigator’s opinion, would exclude the patient from the study"}
• {"criterion_text":"- Pregnant or parturient or breastfeeding woman or absence of contraceptionn"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"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."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessments at post-operative day 90; overall postsurgical morbidity graded by Dindo/Clavien classification and CCI score; pancreatic fistula graded by ISGPF criteria; readmission rates and length of hospital stay recorded."}
• {"endpoint_text":"- Correlation between post-operative bacteriological samples and intraoperative bile samples","definition_or_measurement_approach":"Correlation analysis between bacteriological samples collected post-operatively and intraoperative bile samples."}
• {"endpoint_text":"- Bacteriological resistance profiles","definition_or_measurement_approach":"Characterisation of bacteriological resistance profiles from cultured isolates."}
• {"endpoint_text":"- Incidence of fungal contamination","definition_or_measurement_approach":"Incidence measurement of fungal contamination based on culture results."}
• {"endpoint_text":"- Correlation between bacteriological and fungal contaminations","definition_or_measurement_approach":"Analysis of correlation between bacteriological and fungal contamination findings."}
• {"endpoint_text":"- Incremental cost per infectious complications avoided","definition_or_measurement_approach":"Health economic analysis calculating incremental cost per infectious complication avoided."}

France

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

626

Number Of Sites

27

Number Of Participants

326

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France