A randomized trial to visualize extrahepatic biliary structures with or without indocyanine green in patients undergoing difficult laparoscopic cholecystectomy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of ICG in
研究概览
简要总结
Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of symptomatic gall stone disease which is a major health problem affecting 1.39 per 100 person-years. Surgeons often encounter a ―Difficult Gall bladder during which achieving Critical view of safety is difficult and unsafe. Additionally, anatomical variations, such as a short cystic duct or low-lying gallbladder , complicate the procedure and heighten the risk of bile duct injury .Dense adhesions ,previous surgeries or inflammation can obscure the surgical field, making the identification and dissection of the cystic duct and artery difficult. Fluorescent cholangiography using ICG will enable real-time identification of the cystic duct , common hepatic duct and common bile duct ,as well as accessory hepatic ducts during the dissection of the triangle of Calot. This safe and simple technique is helpful in improve safety in difficult cases of laparoscopic cholecystectomy and thereafter avoiding bile duct injury.In this study, we wish to evaluate the impact of ICG in improving operative efficacy and safety during difficult laparoscopic cholecystectomy, along with long term outcomes and Quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Surgical Cholecystectomy Score (SCS) 2 or more.
排除标准
- •1.Age < 18 yrs or > 70 yrs 2.Prior history of hepato-biliary surgery 3.Allergy to ICG dye 4.Hepatobiliary malignancy 5.Pregnant and lactating females.
结局指标
主要结局
To evaluate the effectiveness of ICG in
时间窗: At time of surgery
visualization of extrahepatic biliary structures
时间窗: At time of surgery
during difficult laparoscopic cholecystectomy by
时间窗: At time of surgery
visual analogue score (VAS) and mean green
时间窗: At time of surgery
colour intensity (GCI).
时间窗: At time of surgery
次要结局
- 1.To compare the rate of bile duct injury in both(groups)
研究者
Dr Virinder Kumar Bansal
All India Institute of Medical Sciences, New Delhi
