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LOW DOse vs standard dose and administration TIme in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy: a randomised clinical trial.
EU CTIS ID: 2025-522535-33-00
What this study is testing
To analyze the differences between treatment groups [standard dose of 2.5 mg administered >3 hours preoperatively vs. reduced dose (0.25 mg) administered immediately preoperatively (15 minutes)], during laparoscopic cholecystectomy (LC), in terms of: Visualization of extrahepatic biliary structures. Degree of visualization of these structures. Degree of background hepatic fluorescence disturbance. Perceived utility of the technique across treatment groups.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient (≥18 years old) who is able to understand and sign the informed consent form.
- Indication for: a) Elective laparoscopic cholecystectomy (LC) due to: Symptomatic cholelithiasis (history of biliary colic, acute calculous cholecystitis, choledocholithiasis, ascending acute lithiasic cholangitis, or acute biliary pancreatitis); Gallbladder polyps with indication for laparoscopic surgery. b) Early LC indication (<72 hours from hospital admission) for: Acute calculous cholecystitis; Acute acalculous cholecystitis; Complicated biliary colic. c) Indication for delayed emergency LC.
You likely can't join if
- Patient under 18 years of age.
- Inability to understand the information required to participate in the study or to complete follow-up.
- Pregnancy or breastfeeding.
- Chronic kidney disease (Stage > IIIb).
- History of adverse reactions or allergies to indocyanine green (ICG).
- Confirmed adverse reactions or allergies to iodinated contrast agents.
See the full eligibility criteria
- Adult patient (≥18 years old) who is able to understand and sign the informed consent form.
- Indication for: a) Elective laparoscopic cholecystectomy (LC) due to: Symptomatic cholelithiasis (history of biliary colic, acute calculous cholecystitis, choledocholithiasis, ascending acute lithiasic cholangitis, or acute biliary pancreatitis); Gallbladder polyps with indication for laparoscopic surgery. b) Early LC indication (<72 hours from hospital admission) for: Acute calculous cholecystitis; Acute acalculous cholecystitis; Complicated biliary colic. c) Indication for delayed emergency LC.
- Patient under 18 years of age.
- Inability to understand the information required to participate in the study or to complete follow-up.
- Pregnancy or breastfeeding.
- Chronic kidney disease (Stage > IIIb).
- History of adverse reactions or allergies to indocyanine green (ICG).
- Confirmed adverse reactions or allergies to iodinated contrast agents.
- Functional thyroid disorders (e.g., hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
- Non-deferrable/emergency gallbladder surgery.
- Primary open (laparotomic) cholecystectomy.
- Preoperative suspicion of gallbladder carcinoma.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.