Study comparing low and standard doses of Indocyanine Green for fluorescence imaging during gallbladder removal surgery in patients with gallstones

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What is this study about?

This study focuses on patients with symptomatic cholelithiasis, a condition where gallstones cause symptoms such as pain and discomfort. The study examines different approaches during laparoscopic cholecystectomy, which is a minimally invasive surgery to remove the gallbladder. The research uses indocyanine green, a special dye that helps surgeons see the bile ducts more clearly during the operation.

The study compares two different ways of using the dye during surgery. One group of patients receives a standard dose of the dye several hours before surgery, while the other group receives a smaller dose just before the operation. The purpose is to determine which method provides better visualization of the bile ducts during the surgical procedure.

During the operation, doctors use a special camera system that can detect the dye, making certain parts of the body’s structures glow and become more visible. This helps them see important structures more clearly during the surgery. The study will evaluate how well doctors can see these structures and how helpful the technique is during the operation.

1 Medication administration – Group 1

If assigned to the first group, you will receive a standard dose of 2.5 mg of indocyanine green through intravenous administration more than 3 hours before the surgery

2 Medication administration – Group 2

If assigned to the second group, you will receive a reduced dose of 0.25 mg of indocyanine green through intravenous administration 15 minutes before the surgery

3 Surgical procedure

The surgical team will perform a laparoscopic cholecystectomy (minimally invasive gallbladder removal surgery)

During the surgery, special imaging equipment will be used to observe how the administered dye highlights the bile ducts

The surgical team will evaluate the visibility of bile ducts at two specific moments: before and after the dissection of the hepatocystic triangle (the area around the gallbladder)

4 Evaluation

The surgical team will assess:

How well the bile ducts can be seen before the dissection

How well the bile ducts can be seen after the dissection

The quality of visualization (rated as poor, good, or excellent)

How useful the fluorescence technique was during surgery

The level of background liver fluorescence interference

5 Post-surgery monitoring

Your recovery will be monitored for any complications

The length of your hospital stay will be recorded

The total duration of the surgery will be documented

Who Can Join the Study?

Must be at least 18 years old
Must be able to understand and sign the informed consent form
Must have one of the following conditions requiring surgery:
- Symptomatic gallstones with:
  - History of biliary pain (severe pain in upper right abdomen)
  - Inflammation of the gallbladder due to stones
  - Stones in the bile duct
  - Infection of the bile ducts due to stones
  - Inflammation of the pancreas due to gallstones
- Gallbladder polyps (abnormal tissue growths) that require removal
Must need one of these types of gallbladder surgery:
- Planned (elective) keyhole surgery to remove the gallbladder
- Urgent surgery within 72 hours of hospital admission
- Delayed emergency surgery
Both men and women can participate

Who Cannot Join the Study?

Age below 18 years or above 65 years
Known allergy or sensitivity to ICG (Indocyanine Green dye used in the procedure)
Pregnancy or breastfeeding
Severe liver disease or dysfunction
Severe kidney disease or dysfunction
Active thyroid disease
Previous surgery in the upper abdomen
Emergency surgery requirement
Inability to provide informed consent
Known iodine allergy (as ICG contains sodium iodide)
Severe heart disease
Body Mass Index (BMI) greater than 35 (severe obesity)
Active infection or inflammation in the gallbladder area
Participation in another clinical trial within the past 30 days
Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country	Status
Complejo Asistencial De Zamora Hospital Provincial De Zamora	Zamora	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.11.2025

Trial locations

Investigated drugs:

Indocyanine Green

Based on the provided trial data, there is only one medication involved:

Indocyanine green (ICG) – This is a medical dye used in fluorescence imaging during laparoscopic gallbladder removal surgery. When injected into the bloodstream, it helps surgeons better visualize the bile ducts and other important structures during the operation. The dye glows when exposed to near-infrared light, making it easier for surgeons to see critical anatomical structures and avoid complications during surgery.

Cholelithiasis – A condition where gallstones form in the gallbladder or bile ducts. These stones develop when substances in bile, primarily cholesterol and bilirubin, crystallize and clump together. The stones can vary in size from tiny grains to several centimeters in diameter. When symptomatic, the condition typically causes pain in the upper right abdomen, particularly after meals. The presence of gallstones can lead to inflammation of the gallbladder and may cause digestive issues. Some people may have gallstones for years without experiencing any symptoms.

Trial ID:

2025-522535-33-00

Protocol code:

Low-DOTIG

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study comparing low and standard doses of Indocyanine Green for fluorescence imaging during gallbladder removal surgery in patients with gallstones

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?