Comparing Indocyanine green dye and Metylene blue dye for better visualisation of biliary tree structure in laparoscopic cholecystectomy .

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/081592

Enrollment

Registered

2025-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Use of indocyanine green for visualisation of biliary tree in laparoscopic cholecystectomy: one group will receive IV Indocyanine green for visualising biliary tree in laparoscopic cho

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.Timepoint: intraoperative monitoring , on day 1 ,3 ,5 and after 2 weeks	—

Measure

Time frame

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.Timepoint: intraoperative monitoring , on day 1 ,3 ,5 and after 2 weeks

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Secondary

Measure	Time frame
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 . 3.To estimate & compare Nassar grade in both group . 4.Correlation of Nassar grade with surgical rating scale in both group. 5.To estimate & compare operating time, intraoperative complication, conversion to open in both group . Timepoint: intraoperative monitoring and on day 1 & day 3 & day 5 & after 2 weeks	—

Measure

Time frame

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 . 3.To estimate & compare Nassar grade in both group . 4.Correlation of Nassar grade with surgical rating scale in both group. 5.To estimate & compare operating time, intraoperative complication, conversion to open in both group . Timepoint: intraoperative monitoring and on day 1 & day 3 & day 5 & after 2 weeks

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Countries

India

Contacts

Public ContactDr Yeshwant Lamture

All India Institue of Medical Science ,Nagpur

yash18671@gmail.com9960371205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026