A Single-Blinded Randomized Control Trial in Utility of Visualization of Biliary Tract by Indocyanine Green versus Methylene Blue in Adult Patients undergoing Laparoscopic Cholecystectomy in a Tertiary Care Centre
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- This study compares Indocyanine Green (ICG) and Methylene Blue (MB) in visualizing the biliary tract during laparoscopic cholecystectomy to enhance safety and reduce bile duct injury. ICG, with near-infrared fluorescence, is simple, feasible, and cost-effective, aiding in complex cases. MB, widely used in abdominal surgery, helps detect vital structures. By assessing both agents, this study aims to guide best practices for biliary tract identification during surgery.
研究概览
简要总结
This single blinded randmised control trial evaluates the utility of indocyanine green (ICG) and methylene blue (MB) in enhancing biliary tract visualization during laparoscopic cholecystectomy in adult patients at a tertiary care center the study aims to determine which agent provides better visualization of critical biliary structures such as cystic duct and common bile duct to minimize bile duct injuries and improve surgical safety . ICG , administered pre operatively , utilizes near infrared fluorescence imaging for real time visulization , while MB , injected intra operatively , stains the biliary anatomy directly for immediate identification . by comparing these agents , the study seeks to optimize surgical techniques and enhance patient outcomes in routine clinical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 18 years or older scheduled for laparoscopic cholecystectomy.
- •2.Diagnosis of symptomatic cholelithiasis requiring surgical intervention.
- •3.Ability to provide informed consent for participation in the study.
- •4.Adequate renal function, as determined by serum creatinine levels within normal range.
- •5.Ability to tolerate general anesthesia and laparoscopic surgery.
排除标准
- •1.Known allergy or contraindication to Indocyanine Green (ICG) or Methylene Blue (MB).
- •2.History of significant liver dysfunction or liver disease, including cirrhosis.
- •3.Pregnancy or breastfeeding status.
- •4.Presence of Ca gallbladder, severe cardiovascular disease, uncontrolled hypertension, or significant pulmonary disease.
结局指标
主要结局
This study compares Indocyanine Green (ICG) and Methylene Blue (MB) in visualizing the biliary tract during laparoscopic cholecystectomy to enhance safety and reduce bile duct injury. ICG, with near-infrared fluorescence, is simple, feasible, and cost-effective, aiding in complex cases. MB, widely used in abdominal surgery, helps detect vital structures. By assessing both agents, this study aims to guide best practices for biliary tract identification during surgery.
时间窗: intraoperative monitoring , | on day 1 ,3 ,5 and after 2 weeks
次要结局
- 1.To estimate & compare the achievement of critical view of safety in Indocyanine green group & methylene blue group.(2. The estimate & compare the surgeon satisfaction score as per surgical rating scale in both group .)
研究者
Dr Venkatesh
All India Institue of Medical Science ,Nagpur