Optimization of dose and timing of indocyanine green in laparoscopic cholecystectomies

This study aims to evaluate the optimal timing and dosage of indocyanine green (ICG) dye to enhance intraoperative visualization of the gallbladder and surrounding structures during keyhole (laparoscopic) gallbladder removal surgery.

ICG is approved by the Australian Therapeutic Goods Administration (TGA) for use as an imaging agent. It allows surgeons to visualize the extrahepatic biliary anatomy in patients undergoing laparoscopic cholecystectomy, in real time, without the need for complex imaging equipment. While ICG has been used in similar settings, the most effective timing and dosing to achieve optimal imaging remain unclear.

This randomised controlled trial will compare different combinations of ICG doses and timing of administration to identify the most effective approach, with the goal of improving surgical safety and outcomes.

Aim:

  • Primary Aim: To determine the optimal timing (within 30 - 60 min vs more than 120 min) and dose (1.25mg vs 2.5mg) for administering indocyanine green for optimal visualization of the extrahepatic biliary anatomy in patients undergoing laparoscopic cholecystectomy as a day case.

Secondary Aim: To determine the practicability and assessment in use of NIFR-ICG from the surgeons’ and anesthetists’ perspective.

 
 

Status: Active

Site: St Vincent’s Hospital Melbourne

Ethics: 282/24

Clinical Trial Registration Ref: 109882

Principal Investigator: Mr Brett Knowles

 
 

Eligibility

Inclusion

  • Adults ≥18 years of age

  • Requiring laparoscopic cholecystectomy for benign gall bladder condition

  • Ability to understand English

  • Able to give informed consent

Exclusion

  • Below the age of 18 years old

  • Pregnant/lactating females

  • After hours laparoscopic cholecystectomy

  • Liver and renal derangement

  • Previous adverse reaction to ICG or iodinated contrast

  • Patients with hyperthyroidism

  • First patient on the AM theatre list

Outcome Measures

Primary outcome

  • To determine the optimal timing (30–60 minutes vs. more than 120 minutes) and dose (1.25 mg vs. 2.5 mg) of indocyanine green (ICG) administration for the best visualization of extrahepatic biliary anatomy during laparoscopic cholecystectomy.

     

    Secondary outcomes

  • To determine the biliary identification time when using ICG in laparoscopic cholecystectomies. Time will be determined by a stopwatch and wall clock.

  • To determine the cost effectiveness of ICG use in laparoscopic cholecystectomies. Data on resource and hospital costs will be extracted from the cost and revenue data explorers provided by the hospital.