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New treatment option for Laparoscopic Cholecystectomy Surgery
Official title Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.
ClinicalTrials.gov ID: NCT07195331
What this study is testing
What is Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.?
Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for laparoscopic cholecystectomy surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Introduction: This protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- Signed informed consent.
- Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).
You likely can't join if
- Age \<18 years.
- Pregnancy or lactation.
- Chronic kidney disease (stage \>IIIb).
- ICG allergy.
- Allergy to other iodinated contrast
- Functional thyroid disease.
See the full eligibility criteria
- Age ≥18 years.
- Signed informed consent.
- Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).
- Age \<18 years.
- Pregnancy or lactation.
- Chronic kidney disease (stage \>IIIb).
- ICG allergy.
- Allergy to other iodinated contrast
- Functional thyroid disease.
- Emergency non-deferrable surgery.
- Open approach.
- Suspicion of gallbladder cancer.
- Inability to understand the study.
The study team makes the final eligibility decision.
Where it's taking place
- Salamanca, Salamanca, Spain
- Zamora, Zamora, Spain
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salamanca, Salamanca, Spain; Zamora, Zamora, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.