Comparing laparoscopic ultrasound and fluorescence imaging with indocyanine green to map bile ducts during difficult laparoscopic gallbladder removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective interventional study in which each participant will receive both laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) during the same operation to allow direct within-patient comparison. LUS is performed first, followed by ICG fluorescence imaging prior to dissection of Calot's triangle using a standardized sequence. The primary endpoint is successful identification of the critical junction; secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, and intra- and postoperative complications. The trial focuses on cases anticipated to be technically difficult, such as acute cholecystitis, prior upper abdominal surgery, prior biliary disease, or obesity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Written informed consent provided.
3. Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following:

   * Acute cholecystitis.
   * Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography.
   * Prior upper abdominal surgery.
   * Obesity (Body Mass Index ≥ 30 kg/m²).

Exclusion Criteria:

1. Known allergy to ICG or iodine.
2. Pregnancy or breastfeeding.
3. High risk of choledocholithiasis (ESGE guidelines).
4. Thyroid disease.
5. Suspected gallbladder malignancy.
6. ASA class IV-V.
7. Chronic kidney disease stage \> IIIb.
8. Planned open cholecystectomy.

Where it's running

• Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
  Sant Joan Despí, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Andrea Sanz LLorente, M.D.
• Email: andreasanz@uic.es
• Phone: +34 93 5531200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.