Study to evaluate benefit of ICG dye on operative efficacy in patients undergoing difficult laparoscopic cholecystectomy.

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076948

Enrollment

208

Registered

2024-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K80- Cholelithiasis

Interventions

Intervention1: Indocyanine Green dye: ICG dose of 0.2 - 0.4 mg/kg body weight will be given intravenously 8- 10 hours before surgery Intervention2: ICG ARM: ICG dose of 0.2 - 0.4 mg/kg body weight wi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Surgical Cholecystectomy Score (SCS) 2 or more

Exclusion criteria

Exclusion criteria: 1.Age 70 yrs 2.Prior history of hepato-biliary surgery 3.Allergy to ICG dye 4.Hepatobiliary malignancy 5.Pregnant and lactating females

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of ICG in visualization of extrahepatic biliary structures during difficult laparoscopic cholecystectomy by visual analogue score (VAS) and mean green colour intensity (GCI).Timepoint: At time of surgery	—

Secondary

Measure	Time frame
1.To compare the rate of bile duct injury in both groups 2.Conversion to open 3.Operating Time 4.To measure the length of hospital stay 5.To evaluate postoperative complications bile leak & SSITimepoint: At time of surgery 1 week 4 weeks 6 months	—

Countries

India

Contacts

Public ContactDr U Rohit

All India Institute of Medical Sciences, New Delhi

dryashvant.r@gmail.com9911337726

Outcome results

None listed

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