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Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Sant Joan Despí, Barcelona, Spain
Start Date
April 1, 2025
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2027
Last Updated
February 10, 2026
62
ESTIMATED participants
Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)
DIAGNOSTIC_TEST
Lead Sponsor
Consorci Sanitari Integral
Collaborators
NCT07454629
NCT07440940
Data Source & Attribution
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