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The adjuvant use of indocyanine green dye to facilitate the visibility of extrahepatic biliary ducts, to prevent injury during difficult cholecystectomy:A randomised trial

Impact of Indocyanine Green Fluorescence on Surgical Precision in Difficult Cholecystectomy - A Randomized Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075575
Enrollment
56
Registered
2024-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: Indocyanine Green: dose 0.2 mg/kg body weight of indocyanine Green will be given intravenously night 10 hours before surgery Control Intervention1: control: no icg will be used

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age = 18 years 2 Gall stone disease patients with moderate and high risk of difficult cholecystectomy on preoperative risk assessment scale 3 Hemodynamically stable 4 Fit for General anaesthesia • Laparoscopic cholecystectomy indicated either interval or immediate( within 72 hrs of presentation).

Exclusion criteria

Exclusion criteria: 1 Allergy to Indocyanine green (ICG) 2 Patients with low risk of difficult cholecystectomy on preoperative risk assessment scale 3 Patient for which consent could not be obtained.

Design outcomes

Primary

MeasureTime frame
Operative time from insertion of ports to achieving critical view of safety (CVS).Timepoint: once on operation table

Secondary

MeasureTime frame
blood lossTimepoint: once on operation table;Bile duct injuryTimepoint: once on operation table;Conversion to openTimepoint: once on operation table;Post operative bile leakTimepoint: once on operation table;Hospital stayTimepoint: once on operation table

Countries

India

Contacts

Public ContactDr Vishnukant Pandey

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

dranitadharbhan@gmail.com09810198239

Outcome results

None listed

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