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Study on Indocyanine Green for Patients Undergoing Emergency Surgery for Acute Cholecystitis

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the use of indocyanine green in patients with acute cholecystitis, a condition where the gallbladder becomes inflamed, often requiring urgent surgery known as a cholecystectomy. The trial aims to determine if using indocyanine green can help reduce the time needed for this surgery. Indocyanine green is a substance that, when injected, can help surgeons see the bile ducts more clearly during the operation, potentially reducing the risk of injury.

The study involves patients who need an urgent laparoscopic cholecystectomy, which is a minimally invasive surgery to remove the gallbladder. Participants will receive indocyanine green before the surgery. The main goal is to see if this approach can shorten the surgical time by at least 10 minutes compared to the traditional method. This could make the procedure safer and more efficient.

During the trial, participants will undergo the surgery with the use of indocyanine green, and the time taken from the first incision to the closure of the skin will be recorded. The study is designed to provide valuable insights into improving surgical outcomes for patients with acute cholecystitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing the informed consent form, indicating understanding and agreement to participate in the study.

    Eligibility requires being over 18 years old and having a medical indication for urgent laparoscopic cholecystectomy due to acute cholecystitis.

  2. Step 2

    Preoperative preparation

    Before surgery, indocyanine green is administered intravenously. This is a dye used to help visualize the bile ducts during surgery.

    The purpose of using indocyanine green is to reduce the surgical time by at least 10 minutes compared to the conventional procedure.

  3. Step 3

    Surgical procedure

    The surgery performed is an urgent laparoscopic cholecystectomy, which is the removal of the gallbladder using minimally invasive techniques.

    The primary goal is to complete the surgery efficiently while minimizing the risk of injury to the bile duct.

  4. Step 4

    Postoperative care

    After the surgery, recovery and monitoring are conducted to ensure proper healing and to observe any immediate effects of the procedure.

    The surgical time, defined as the duration from the first incision to the closure of the skin, is recorded as a primary measure of the study's success.

Who can join the trial?

4 criteria

  • Patients must need an urgent **laparoscopic cholecystectomy**. This is a type of surgery to remove the gallbladder using small cuts in the belly.
  • The reason for the surgery must be **acute cholecystitis**, which is a sudden inflammation of the gallbladder.
  • Patients must be older than 18 years.
  • Patients must have read the study information sheet and signed the informed consent sheet, which means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

8 criteria

  • Patients who are unable to undergo surgery safely.
  • Patients with severe heart or lung problems that make surgery risky.
  • Patients with a known allergy to **indocyanine green (ICG)**, a dye used during the procedure.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe liver disease.
  • Patients who have had previous surgery on the bile duct.
  • Patients with a history of severe allergic reactions.
  • Patients who are unable to give informed consent.
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Investigated drugs

Indocyanine Green is a dye used in medical imaging. In this trial, it is administered before surgery to help surgeons see the bile ducts more clearly during a cholecystectomy, which is the removal of the gallbladder. The goal is to reduce the time needed for the surgery by making it easier to identify important structures.

What is already known about the treatment

Indocyanine Green – Indocyanine Green is administered intravenously and is used during surgical procedures. It is currently being studied in clinical trials for its effectiveness in reducing surgical time during urgent cholecystectomy for acute cholecystitis. The main therapeutic indication is to aid in the identification of the extrahepatic bile duct, potentially preventing iatrogenic injury. At the molecular level, Indocyanine Green works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, allowing surgeons to visualize structures during surgery. It is classified as a diagnostic agent.

Investigated diseases

Acute Cholecystitis – Acute cholecystitis is an inflammation of the gallbladder, often caused by gallstones blocking the cystic duct. This blockage leads to a buildup of bile, causing irritation and swelling of the gallbladder. Symptoms typically include severe pain in the upper right abdomen, fever, and nausea. The condition can progress to more severe complications if not addressed, such as infection or rupture of the gallbladder. It is considered a medical emergency and often requires surgical intervention to remove the gallbladder.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518677-34-00Protocol codeINDURGTRIAL2022Estimated enrolment440 patientsSponsorFundacio Parc Tauli

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