Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- 30-day postoperative infection rate
研究概览
简要总结
This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.
详细描述
This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: over 18 years;
- •Diagnosed as primary HCC according to the EASL criteria and plan to receive hepatectomy;
- •Child-Pugh A class;
- •No history of antibiotics in 1 week before surgery, except for antimicrobial prophylaxis in the 24h before surgery.
- •No evidence of infection during preoperational assessment
排除标准
- •Underwent hepatectomy combined with resection of other organs, except for gallbladder;
- •Found obvious infection during operation;
- •Combination with other operations, such as biliary reconstruction or tube drainage, bile duct exploration and stone remove, etc.;
- •Allergic to the antibiotics used in the 24h before surgery;
- •Emergency surgery;
- •Tumor rupture;
- •Did not underwent hepatectomy because of any reasons;
- •Admission to ICU after surgery;
- •ASA grade ≥ 3;
- •Denial of informed consent.
研究组 & 干预措施
Postoperative antimicrobial prophylaxis
Patients will receive postoperative antimicrobial prophylaxis for 3 days in 24 hours after hepatectomy.
干预措施: postoperative antimicrobial prophylaxis (Drug)
No postoperative antimicrobial prophylaxis
Patients will receive no antibiotics after hepatectomy, unless the clinicians suggest he/she need antibiotics to treat or prevent infection.
干预措施: No postoperative antimicrobial prophylaxis (Other)
结局指标
主要结局
30-day postoperative infection rate
时间窗: 30 days after hepatectomy
the incidence rate of postoperative infection occurred in 30 days after surgery, including surgical site infections, distant infection or infection from unknown sources
次要结局
- Postoperative complication rate(3 months after hepatectomy)
- Surgical site infection rate(30 days after hepatectomy)
- Severe infection rate(30 days after hepatectomy)
- Distant infection rate(30 days after hepatectomy)
研究者
Ming Kuang
Professor
First Affiliated Hospital, Sun Yat-Sen University