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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Since no specific medication name is provided in the source data, I can create a description for the implied medication (Indocyanine Green - ICG) which is commonly used in near-infrared fluorescence cholangiography: Indocyanine Green - A sterile, water-soluble fluorescent dye administered intravenously that is used for diagnostic imaging during laparoscopic cholecystectomy procedures. This medication belongs to the class of diagnostic agents and works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, allowing surgeons to visualize biliary structures clearly during surgery. ICG is primarily used in medical imaging for real-time visualization of anatomical structures, particularly in hepatobiliary surgery, and has established safety profile with minimal side effects when administered at standard clinical doses.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522535-33-00Protocol codeLow-DOTIGEstimated enrolment122 patientsSponsorFundacion De Investigacion Biomedica De Salamanca

sourced from the EU Clinical Trials Register and site verification

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