Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

Recruiting now · Not applicable

Conditions studied: Cholecystectomy

In brief

This is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection. The primary endpoint is the successful identification of the critical junction. Secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, intraoperative and postoperative complications.

Key facts

Study ID

NCT07400237

Run by

Consorci Sanitari Integral

People needed

62

Starts

2025-04-01

Expected to finish

2027-12-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Written informed consent provided.
• 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).

You may not qualify if…

• Known allergy to ICG or iodine.
• Pregnancy or breastfeeding.
• High risk of choledocholithiasis (ESGE guidelines).
• Thyroid disease.
• Suspected gallbladder malignancy.
• ASA class IV-V.
• Chronic kidney disease stage > IIIb.
• Planned open cholecystectomy.

Where it is running

• Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral — Sant Joan Despí, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.