跳至主要内容
临床试验/CTRI/2024/11/076948
CTRI/2024/11/076948招募中2 期

A randomized trial to visualize extrahepatic biliary structures with or without indocyanine green in patients undergoing difficult laparoscopic cholecystectomy.

All India Institute of Medical Sciences , New Delhi1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2025年6月17日最近更新:

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

发起方
All India Institute of Medical Sciences , New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Virinder Kumar Bansal

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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