Optimization of Indocyanin Green (ICG) Administration for Enhanced Visualization of Extrahepatic Biliary System during Laparoscopic Cholecystectomy - A Pilot Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To compare effectiveness of preoperative ICG administration at 1 hr, 4-6hrs and 10-12 hrs prior to surgery to enhance intraoperative visualization of etrahepatic bile ducts
研究概览
简要总结
Laparoscopic cholecystectomy is a minimally invasive surgical procedure used to remove the gallbladder, typically due to gallstones or other gallbladder diseases. However, one potential complication of the procedure is bile duct injury (BDI), which occurs when the bile duct is accidentally cut, clipped, or otherwise damaged during the procedure. Reported incidence of BDI varies between 0.2% to 0.7% but it can lead to serious complications such as bile leakage, infection, biliary peritonitis and even long-term health problems if not promptly identified and treated in addition to increased hospital stay and need for further interventions. Intraoperative cholangiography has been a traditional method used to visualize the bile duct anatomy during cholecystectomy but it involves injecting contrast dye into the bile duct and taking X-ray images to identify any abnormalities or injuries. It requires special expertise in technique and its interpretation, additional equipment, radiation exposure, and prolongs the surgical procedure.
An emerging alternative to Intraoperative cholangiography is the use of indocyanine green (ICG) fluorescence imaging. ICG is a fluorescent dye that can be injected intravenously and visualized using specialized imaging systems during surgery. By selectively highlighting the bile duct and surrounding structures, ICG fluorescence imaging allows surgeons to better identify and avoid injuring the bile duct during LC.
However, the timing of ICG administration plays a crucial role in adequate fluorescence of the extra hepatic bile ducts. The reason for this being background fluorescence from liver distorting the perception of bile ducts. If fluorescence imaging is performed immediately after the administration of ICG, the liver will be highly fluorescent while bile ducts will not yet contain enough ICG. On the other hand, if fluorescence imaging is performed too long after the administration of ICG, the fluorescence intensity of the common bile duct (CBD) and liver will be so low that it wouldn’t be conducive to identifying anatomical structures.
Hence in this context, the study being conducted to assess the optimal timing of ICG administration before Laparoscopic Cholecystectomy to enhance the visualization of extra hepatic bile ducts during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients undergoing Laparoscopic Cholecystectomy will be given a choice to participate in the study.
排除标准
- •Age more than 80 years Age less than 18 years Patients with Acute Cholecystitis Patients with Iodine Allergy Patients with allergy to test dose of Indocyanin Green (ICG) Patients with Chronic Liver Disease Patients on Chemotherapy Patients with Hyperthyroid Patients with Obesity.
结局指标
主要结局
To compare effectiveness of preoperative ICG administration at 1 hr, 4-6hrs and 10-12 hrs prior to surgery to enhance intraoperative visualization of etrahepatic bile ducts
时间窗: Outcome will be assessed intraoperatively during surgical procedure.
次要结局
- Visulaisation quality in 1 hr group, 4-6 hrs group & 10-12 hrs group(Outcome will be assessed intraoperatively during surgical procedure.)
- Identification of critical structures in the groups(Outcome will be assessed intraoperatively during surgical procedure.)
研究者
Krishna Kalyan Reddy Janumpalli
National Institute of Gastroenterology and Liver Diseases
