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Optimising the timing and dosage of indocyanine green dye (ICG) to identify extra hepatic biliary anatomy during laparoscopic cholecystectomy.

Randomised Prospective Comparative study for optimising the timing and dosage of indocyanine green dye (ICG) in near infrared cholangiography during laparoscopic cholecystectomy. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088695
Enrollment
96
Registered
2025-06-12
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: K80- Cholelithiasis

Interventions

Intervention1: Group B: Indocyanine green dye given 0.1 mg/kg iv dose , 30 to 45 mins before incision for lap cholecystectomy.: Patients in Group B will be administered single dose of intravenous Indo

Sponsors

Amrita Institute of Mediclal Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults in the above age group of 18 to 80 years, who attend the gastrosurgery out patient department and inpatient department of Amrita institute of medical sciences and hospital, Kochi with gall stone disease with the following indications of laparoscopic cholecystectomy: 1.Surgery for gall stone disease including symptomatic cholelithiasis, acute cholecystitis, chronic cholecystitis, Gallstone pancreatitis 2.Surgery for CBD stones with gb stone 3.Surgery for gall bladder polyp 4.Surgery for gall bladder adenomyomatosis 5.Porcelain GB 6.Acalculous cholecystitis 7.Patients who have consented for the study

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years or more than 80 years. 2. Pregnant or lactating females. 3. Chronic kidney disease (stage IIIb and higher). 4. Previous adverse reaction to iodinated contrast agents. 5. Previous adverse reaction to Indocyanine green dye. 6. Suspicion of or proven gall bladder cancer. 7. Refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
Analyse the difference between different doses (fixed / weight adjusted doses) and ICG administration intervals ( timings) to achieve an optimal visualisation of extrahepatic biliary anatomy- cystic duct during near infrared cholangiography- laparoscopic cholecystectomyTimepoint: During Surgery

Secondary

MeasureTime frame
Analyse the difference between different doses (fixed / weight adjusted doses) and ICG administration intervals ( timings) to achieve an optimal visualisation of extrahepatic biliary anatomy- common bile duct and common hepatic duct during near infrared cholangiography- laparoscopic cholecystectomyTimepoint: During surgery.;Analysing the influence of the body mass index (BMI) on the results of near infrared cholangiography- laparoscopic cholecystectomyTimepoint: During surgery;Analysing the influence of the previous biliary disease (biliary colic, choledocholithiasis, cholecystitis, pancreatitis, cholangitis) and previous liver disease (fatty liver, hepatitis, cirrhosis), on the results of near infrared cholangiography- laparoscopic cholecystectomyTimepoint: During surgery;Analysing the influence of previous biliary interventions (endoscopic retrograde cholangiopancreatography (ERCP), percutaneous cholecystostomy, on the results of near infrared cholangiography- laparoscopic cholecystectomyTimepoint: During surgery;Analysing the rate of intraoperative and postoperative complications related to near infrared Cholangiography- lap cholecystectomyTimepoint: 2 weeks;Analysing the impact of Near infrared cholgiography - lap cholecystectomy on general surgeons and their subjective assessment of the procedure. Timepoint: 2 weeks

Countries

India

Contacts

Public ContactPranav Wadhokar

Department of Surgical Gastroenterology and solid organ transplant ,Amrita Institute Of Medical Sciences, Kochi

sudheerov@aims.amrita.edu9447129111

Outcome results

None listed

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