Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- presence of an organ/space SSI
研究概览
简要总结
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)
详细描述
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 complications 44%, hemorrhagic complications 36.6%, pulmonary complications 35.2%, shock 29.8% and pancreatic fistula 27.9%.
PD is a technically complex procedure with substantial associated morbidity and mortality. Infectious complications have been reported to occur in as many as 30% of patients following open PD.
Biliary colonization that arises from preoperative procedures for biliary drainage closely predicts infectious complications following PD. Besides biliary intervention, nutritional reserve and biliary or pancreatic anastomotic leaks are common factors linked to developing infectious complications following PD.
D'Angelica et al. Recently demonstrated the superiority of Piperacillin-tazobactam compared with cefoxitin as antimicrobial prophylaxis for PD: a randomized clinical trial in JAMA, with a significant reduction of postoperative SSI rate.
One of the main risk factors for infectious complications and especially surgical site infections, but also post-operative pancreatic fistula is bacteriobilia, defined by the bile contamination by microorganism(s) related to preoperative biliary drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Broad spectrum antibioprophylaxis
Antibioprophylaxis with Piperacillin-tazobactam during DPC.
干预措施: Antibioprophylaxis (Piperacillin-tazobactam) (Drug)
Broad spectrum antibiotherapy
5 days Antibiotherapy (Piperacillin-tazobactam) from surgery.
干预措施: 5 days Antibiotherapy (Piperacillin-tazobactam) (Drug)
结局指标
主要结局
presence of an organ/space SSI
时间窗: 90 days after the surgery
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.
次要结局
- Bacteriological resistance profiles(day 90)
- Readmission rates and Duration of hospitalization(day 90)
- Infectious complications at post-operative(day 90)
- Correlation between post-operative bacteriological samples and intraoperative bile samples(day 90)
- Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria(day 90)
- Correlation between bacteriological and fungal contaminations(day 90)