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Optimal route of administration of ICG for safe Laparoscopic cholecystectomy.

Optimal route of administration of ICG for increasing the safety in Laparoscopic Cholecystectomy (ORILAC- TRIAL)- A randomized controlled trial - ORILAC TRIAL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065915
Enrollment
212
Registered
2024-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Interventions

Intervention1: Administration of Indo cyanine green dye intraoperatively for safe laparoscopic cholecystectomy: 10 ml of 0.025mg/ml of ICG bile solution is injected into fundus of gall bladder intraop

Sponsors

Department of Surgical Gastroenterology and GI oncology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: elective and quasi emergency indication for laparoscopic cholecystectomy

Exclusion criteria

Exclusion criteria: 1) Pregnancy or lactation. 2) Previous adverse reactions to ICG. 3) Emergency gallbladder surgery. 4) Previous suspicion of gallbladder cancer. 5) Inability to understand the information about the study. • Refusal to participate in the study. • Perforated GB with peritonitis

Design outcomes

Primary

MeasureTime frame
To assess the quality of visualisation of biliary structures and to measure the fluorescence intensity in the cystic duct and common bile duct junction after ICG injection during laparoscopic cholecystectomyTimepoint: Outcome is assessed after the surgery on the same day of surgery (one time measurement)

Secondary

MeasureTime frame
• To analyse the influence of various factors on the results of NIRF-LC • Body mass index (BMI) • Liver disease (fatty liver, hepatitis & cirrhosis) • Underlying biliary disease (biliary colic, choledocholithiasis, cholecystitis & pancreatitis) • ERCP interventions • Intraoperative (Rate of conversion to open, Inadvertent CBD injury & postoperative complications in NIRFC-LC • Duration of surgery • To assess the extent to which liver fluorescence background (liver to-ducts contrast) was perceived as a disturbance. Timepoint: Outcome is assessed after the surgery on the same day of surgery.(one time measurement)

Countries

India

Contacts

Public ContactArun Raja Alagendran

thanjavur medical college hospital

aravigastro@yahoo.co.in9842435515

Outcome results

None listed

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