Not Yet RecruitingNot Applicable

Acute Cholecystitis Biliary Complications - ICG

Spain296 participantsStarted 2027-01-01

Plain-language summary

Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials. The objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG. This is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years. * Diagnosis of acute cholecystitis according to Tokyo Guidelines (TG18) criteria. * Planned urgent/emergency laparoscopic cholecystectomy during the index admission, as determined by the treating surgical team. * Ability to provide written informed consent prior to surgery. Exclusion Criteria: * Known hypersensitivity or contraindication to indocyanine green (ICG) or its excipients. * Pregnancy or breastfeeding. * Clinical situation preventing protocol implementation or informed consent (e.g., life-threatening emergency requiring immediate surgery without time for study procedures). * Primary open cholecystectomy planned (i.e., not intended laparoscopic approach). * Any condition that, in the investigator's opinion, makes participation unsafe or not feasible.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Clinically Relevant Biliary Complications

Timeframe: Within 90 days after surgery

Trial details

NCT IDNCT07481760

SponsorHospital del Mar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Ana Maria Gonzalez Castillo, ACBC Trial Ppal Investigator

+34665126866 amgonzalezcastillo@gmail.com

View on ClinicalTrials.gov More Acute Cholecystitis trials