Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

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.

NCT Number	NCT07400237
Lead Sponsor	Consorci Sanitari Integral Collaborators: Hospital Moisés Broggi de Sant Joan Despí, Barcelona, Hospital Clínico Universitario de Valencia, Hospital Germans Tríes i Pujol de Badalona, Hospital Joan XXIII, Tarragona, Consorcio Parc de Salut Mar, Hospital del Mar, Hospital Mutua de Terrassa
Conditions	Cholecystectomy
Enrollment	62 participants
Start Date	2025-04-01
Primary Completion	2026-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-10