Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000093482p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimization of indocyanine green use in gall bladder removal surgeries
Scientific title
Optimization of dose and timing of indocyanine green in laparoscopic cholecystectomies
Secondary ID [1] 313326 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OPTIC-G
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptomatic cholelithiasis 335681 0
other benign gall bladder conditions 335682 0
cholecystitis 335680 0
Condition category
Condition code
Oral and Gastrointestinal 332640 332640 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 332242 332242 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dose and timing of indocyanine green (ICG) administered intravenously by the anaesthetist and noted on the study case report form.
Arm 1: 1.25mg of ICG administered 30 to 60 minutes prior to surgery
Arm 2: 1.25mg of ICG administered more than 120 minutes before surgery
Arm 3: 2.5mg of ICG administered 30 to 60 minutes prior to surgery
Arm 4: 2.5mg of ICG administered more than 120 minutes before surgery

There is no limit to the maximum amount of time before surgery. This time will be noted in the case report form.
Intervention code [1] 329907 0
Treatment: Drugs
Comparator / control treatment
Dose and timing will be compared between groups.

Arm 1: 1.25mg of ICG administered 30 to 60 minutes prior to surgery compared to
Arm 2: 1.25mg of ICG administered more than 120 minutes before surgery

Arm 3: 2.5mg of ICG administered 30 to 60 minutes prior to surgery compared to
Arm 4: 2.5mg of ICG administered more than 120 minutes before surgery
Control group
Dose comparison

Outcomes
Primary outcome [1] 340143 0
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 The contrast between the liver, gallbladder, cystic duct, and common bile duct (CBD) will be evaluated by measuring luminance intensities using the ImageJ image-processing program. The visibility of the gallbladder and bile ducts will be assessed by three board-certified surgeons, blinded to the timing of ICG administration, based on surgical images. Visibility will be graded as (1=poor, 2= sufficient, 3= fair, 4= good, 5= excellent) from start of surgery to initial visualisation of the following structures (cystic duct (CD), common bile duct (CBD), CD-CBD junction, CD-gallbladder junction, common hepatic duct and anatomical variations). Median luminance intensity ratios of gallbladder/liver, cystic duct/liver, and CBD/liver will be calculated for analysis.
Timepoint [1] 340143 0
The time points of assessment will be at the time of before dissection of the hepatocystic triangle and after dissection of the hepatocystic triangle.
Secondary outcome [1] 442969 0
To determine conversion to open when ICG is used in laparoscopic cholecystectomies. This will be determined by the research coordinator who will be present during the case or from operation notes if necessary.
Timepoint [1] 442969 0
During laparoscopic cholecystectomy
Secondary outcome [2] 441508 0
To determine the biliary identification time when using ICG in laparoscopic cholecystectomies. Time will be determined by a stop watch and wall clock.
Timepoint [2] 441508 0
During laparoscopic cholecystectomy
Secondary outcome [3] 442970 0
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 created by the hospital.
Timepoint [3] 442970 0
After laparoscopic cholecystectomy(postoperative period)

Eligibility
Key inclusion criteria
• Age 18 years and above
• Requiring laparoscopic cholecystectomy for benign indications including cholecystitis, symptomatic cholelithiasis and others
• Able to understand English
• Able to give an informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age below 18 years
• Pregnancy or lactation
• Malignancy
• Requiring cholecystectomy after hours
• Liver and renal derangement
• Previous adverse reaction to indocyanine green or iodinated contrast

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the study, a total sample size of 52 participants, divided into 4 groups of 13 each, was calculated to achieve 80% power with a 95% (0.95) confidence level. This calculation was based on an expected effect size and assumes equal group variances. This sample is adequate to detect a meaningful difference between groups while controlling the risk of type I and II errors.

Descriptive statistics will be used to summarize baseline characteristics of the study groups. For comparative analysis, two-way Analysis of Variance (ANOVA) will be used to compare visualization scores across different ICG regimens. The analysis of the secondary outcomes will be done via a student t-test for the continuous variables (assuming normality of distribution and equivalent variances) and a Fisher test for discrete variables. If continuous data is not normally distributed the Mann-Whitney U test will be used. Values of p<0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27300 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 43390 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304020 0
Commercial sector/Industry
Name [1] 304020 0
Stryker
Country [1] 304020 0
Australia
Funding source category [2] 318034 0
Hospital
Name [2] 318034 0
St Vincent's Hospital Research Endowment Fund
Country [2] 318034 0
Australia
Primary sponsor type
Individual
Name
Brett Knowles, St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320094 0
None
Name [1] 320094 0
Address [1] 320094 0
Country [1] 320094 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304512 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 304512 0
Ethics committee country [1] 304512 0
Australia
Date submitted for ethics approval [1] 304512 0
19/11/2024
Approval date [1] 304512 0
Ethics approval number [1] 304512 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97210 0
Mr Brett Knowles
Address 97210 0
St Vincent's Hospital, 41 Victoria Parade, Fitzroy VIC 3065
Country 97210 0
Australia
Phone 97210 0
+61 394162246
Fax 97210 0
Email 97210 0
[email protected]
Contact person for public queries
Name 97211 0
Lynn Chong
Address 97211 0
St Vincent's Hospital, 41 Victoria Parade, Fitzroy VIC 3065
Country 97211 0
Australia
Phone 97211 0
+61 3 99065629
Fax 97211 0
Email 97211 0
[email protected]
Contact person for scientific queries
Name 97212 0
Lynn Chong
Address 97212 0
St Vincent's Hospital, 41 Victoria Parade, Fitzroy VIC 3065
Country 97212 0
Australia
Phone 97212 0
+61 3 99065629
Fax 97212 0
Email 97212 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.