A Study Comparing Bile Duct Safety in Gallbladder Surgery With and Without Indocyanin Green Fluorescent Dye (ICG)

Comparing the Incidence of Bile Duct Injuries in Laparoscopic Cholecystectomy with and without use of Indocyanin green fluorescence dye (ICG) - A Randomized controlled trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099707

Enrollment

Registered

2025-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: K810- Acute cholecystitis Health Condition 3: K811- Chronic cholecystitis Health Condition 4: K824- Cholesterolosis of gallbladder

Interventions

Intervention1: Indocyaninin Green Fluorescence Dye Guidance: Laparoscopic cholecystectomy performed with the use of Indocyanine Green (ICG) fluorescence dye for biliary anatomy visualization. ICG will

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years to 60 years undergoing elective and emergency laparoscopic cholecystectomy. 2.Patients diagnosed with Acute cholecystitis, chronic cholelithiasis, gall bladder empyema or gallbladder polyps. 3.ASA Physical Status I III.

Exclusion criteria

Exclusion criteria: 1.Suspected or confirmed malignancy of the gallbladder or biliary tract. 2.Known anatomic biliary tract anomalies (e.g. choledochal cysts,biliary atresia). 3.Patients with severe liver dysfunction (e.g. Child-Pugh Class B or C). 4.Pregnant or breastfeeding women. 5.Patients with renal failure (as ICG clearance may be altered)

Design outcomes

Primary

Measure	Time frame
Comparison of the incidence of bile duct injury between ICG fluorescence guided laparoscopic cholecystectomy and Standard laparoscopic cholecystectomy without ICG fluorescence.Timepoint: From intraoperative period up to postoperative hospital stay,1 month and 3 month follow up.	—

Secondary

Measure	Time frame
Rate of successful identification of the critical view of safety during dissectionTimepoint: Intraoperative period;Operative time measured from skin incision to port closure in minutesTimepoint: Intraoperative period;Intraoperative complications including bleeding bile duct injury gallbladder perforation conversion to open surgery Timepoint: Intraoperative period;Postoperative complications like fever wound infection bile leak jaundiceTimepoint: Postoperative hospital stay one month three months follow up;Duration of hospital stay (number of days from surgery to discharge)Timepoint: Postoperative period until discharge;Need for re-interventionTimepoint: Postoperative hospital stay one month three months follow up;Time taken for identification of key anatomical structures like cystic duct cystic artery common bile ductTimepoint: Intraoperative period	—

Measure

Time frame

Rate of successful identification of the critical view of safety during dissectionTimepoint: Intraoperative period;Operative time measured from skin incision to port closure in minutesTimepoint: Intraoperative period;Intraoperative complications including bleeding bile duct injury gallbladder perforation conversion to open surgery Timepoint: Intraoperative period;Postoperative complications like fever wound infection bile leak jaundiceTimepoint: Postoperative hospital stay one month three months follow up;Duration of hospital stay (number of days from surgery to discharge)Timepoint: Postoperative period until discharge;Need for re-interventionTimepoint: Postoperative hospital stay one month three months follow up;Time taken for identification of key anatomical structures like cystic duct cystic artery common bile ductTimepoint: Intraoperative period

—

Countries

India

Contacts

Public ContactAiswaryaa B

Aarupadai Veedu Medical College

aakmal04@gmail.com8939932440

Outcome results

None listed

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