Defining the ideal dose of indocyanine green dye for the identification of biliary structures during surgical treatment to remove the gallbladder

Defining the ideal indocyanine green dose for fluorescent cholangiography during laparoscopic cholecystectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10190039

Enrollment

Registered

2022-05-30

Start date

2020-09-30

Completion date

Unknown

Last updated

2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign gallbladder diseases: cholelithiasis, adenomyomatosis Digestive System Cholelithiasis

Interventions

The study defines the ideal range of ICG dose (mg/kg), timing of administration and dilution for fluorescent cholangiography and is divided into two parts: the first one identifies the best four ICG d

then these four doses are tested in four groups (four patients for each group) to confirm the defined range of ICG dose

in the second part of the study the ICG dose is tested in a series of 50 consecutive cholecystectomies to confirm the optimal dose, dilution and administration timing. Enrolled patien

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years old 2. Indication for cholecystectomy (gallstones disease; adenomyomatosis) 3. Ability to understand and follow study procedures 4. Having provided signed consent

Exclusion criteria

Exclusion criteria: 1. Known allergy to iodides 2. Coagulopathy 3. Pre-existing liver disease 4. Pregnancy 5. Acute cholecystitis 6. BMI =40 kg/m²

Design outcomes

Primary

Measure	Time frame
The definition of the ideal range of ICG dose (mg/kg) for fluorescent cholangiography. Fluorescence intensity of biliary structures and liver parenchyma is measured through two evaluations twice for each patient during the same surgical procedure (before and after dissection of Calot's triangle): 1. Subjective evaluation by the operating surgeon and ranked as 1 (absent), 2 (poor) 3 (medium), 4 (high) 2. Objective evaluation performed using ImageJ software(*) on selected pictures captured on recorded surgical procedures Evaluation is performed using the ImageJ software: 1. On cystic duct and on common bile duct if visible, in order to define the fluorescence intensity 2. On liver parenchyma: on the left/right side of the infundibulum (next to the cystic duct), in order to define the liver background. The range of ICG dose is defined by the best balance between the highest fluorescence intensity of biliary structure associated with the lowest liver parenchyma background achievable. Data obtained by objective evaluation (through the ImageJ software) are used to define the signal to background ratio (SBR) = mean signal of biliary structures fluorescence intensity / mean signal of liver background to strengthen data.	—

Measure

Time frame

The definition of the ideal range of ICG dose (mg/kg) for fluorescent cholangiography. Fluorescence intensity of biliary structures and liver parenchyma is measured through two evaluations twice for each patient during the same surgical procedure (before and after dissection of Calot's triangle): 1. Subjective evaluation by the operating surgeon and ranked as 1 (absent), 2 (poor) 3 (medium), 4 (high) 2. Objective evaluation performed using ImageJ software(*) on selected pictures captured on recorded surgical procedures Evaluation is performed using the ImageJ software: 1. On cystic duct and on common bile duct if visible, in order to define the fluorescence intensity 2. On liver parenchyma: on the left/right side of the infundibulum (next to the cystic duct), in order to define the liver background. The range of ICG dose is defined by the best balance between the highest fluorescence intensity of biliary structure associated with the lowest liver parenchyma background achievable. Data obtained by objective evaluation (through the ImageJ software) are used to define the signal to background ratio (SBR) = mean signal of biliary structures fluorescence intensity / mean signal of liver background to strengthen data.

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Secondary

Measure	Time frame
1. Best timing for IV ICG administration measured in minutes before surgery. The pre-established administration timing is 1 hour before surgery, and it is eventually modified according to the results of the first part of the study 2. Best dilution of ICG measured in milliliters. Starting from 10 ml dilution with sterile water, it is increased according to the dose identified at the end of the first part of the study	—

Measure

Time frame

1. Best timing for IV ICG administration measured in minutes before surgery. The pre-established administration timing is 1 hour before surgery, and it is eventually modified according to the results of the first part of the study 2. Best dilution of ICG measured in milliliters. Starting from 10 ml dilution with sterile water, it is increased according to the dose identified at the end of the first part of the study

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026