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 years.
Written informed consent provided.
Acute cholecystitis.
Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography.
Known allergy to ICG or iodine.
Pregnancy or breastfeeding.
High risk of choledocholithiasis (ESGE guidelines).
Thyroid disease.
Single group
Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)
Diagnostic testTwo intraoperative imaging modalities will be applied: 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.
Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct
This intraoperative visualization will be assessed separately for laparoscopic ultrasound (LUS) and indocyanine green fluorescence cholangiography (ICG) and recorded as a binary outcome (yes/no) for each technique in each patient using a standardized intraoperative assessment form completed by the operating surgeon. Laparoscopic ultrasound will be performed first, followed by indocyanine green fluorescence cholangiography, according to a predefined and standardized intraoperative sequence. Intraoperative photographic documentation will be obtained for each imaging modality to objectively demonstrate the visualization of the critical biliary junction. Results will be reported as the proportion of patients with successful visualization for each modality and compared using an intra-subject analysis.
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Consorci Sanitari Integral
Lead sponsor
Hospital Moisés Broggi de Sant Joan Despí, Barcelona
Collaborator
Hospital Clínico Universitario de Valencia
Collaborator
Hospital Germans Tríes i Pujol de Badalona
Collaborator
Hospital Joan XXIII, Tarragona
Collaborator
Consorcio Parc de Salut Mar, Hospital del Mar
Collaborator
Hospital Mutua de Terrassa
Collaborator
