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Studying the optimal dosage and timing of intervention (Indocyanin Green administration) in participants undergoing Laparoscopic Cholecystectomy.

Optimization of Indocyanin Green (ICG) Administration for Enhanced Visualization of Extrahepatic Biliary System during Laparoscopic Cholecystectomy - A Pilot Randomized Control Trial - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/079963
Enrollment
75
Registered
2025-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: K802- Calculus of gallbladder without cholecystitis Health Condition 3: K805- Calculus of bile duct without cholangitis or cholecystitis Health Condition 4: K806- Calculus of gallbladder and bile duct with cholecystitis Health Condition 5: K807- Calculus of gallbladder and bile duct without cholecystitis Health Condition 6: K851- Biliary acute pancreatitis Health Condition 7: O- Medical and Surgical

Interventions

Intervention1: Administration of Indocyanin Green (ICG) at different time intervals and dosage to visualize extrahepatic bile duct: Administration of 2.5mg ICG 1 hr before surgery,Administration of 10

Sponsors

Department of Surgical Gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing Laparoscopic Cholecystectomy will be given a choice to participate in the study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 ductsTimepoint: Outcome will be assessed intraoperatively during surgical procedure.

Secondary

MeasureTime frame
Visulaisation quality in 1 hr group, 4-6 hrs group & 10-12 hrs groupTimepoint: Outcome will be assessed intraoperatively during surgical procedure.;Identification of critical structures in the groupsTimepoint: Outcome will be assessed intraoperatively during surgical procedure.

Countries

India

Contacts

Public ContactKrishna Kalyan Reddy Janumpalli

National Institute of Gastroenterology and Liver Diseases

dnb.bh@renovahospitals.com7993089995

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026