Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Visual identification of the biliary tree
研究概览
简要总结
This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy
详细描述
A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (from 18 to 75 years old)
- •suffering from a gall bladder disease
- •with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)
- •accepted to participate in the study.
排除标准
- •Patients with history of previous biliary surgery
- •Patients with abdominal malignancy
- •Patients with advanced chronic liver disease
- •pregnant women
结局指标
主要结局
Visual identification of the biliary tree
时间窗: during the procedure
To measure the % of patients in which investigators can identify visually the extra hepatic biliary system (the CD, CBD, CHD, and any possible anomalies present), during LC.
Visual identification of the cystic artery
时间窗: during the procedure
To measure the % of patients in which investigators can identify visually the cystic artery, during LC.
次要结局
- Compare blood loss(during the procedure)
- Compare operative time(during the procedure)
- Compare blood loss in cc(during the procedure)
- Visual identification of injuries(during and imediatly after the procedure (24 hours))
- Percentage of patients of ICG adverse reactions(Within 24 hour of the procedure)
研究者
Mohammad Ahmad Abd-erRazik
Lecturer of General Surgery
Ain Shams University