About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Written informed consent provided.
Acute cholecystitis.
Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography.
Disqualifiers
Known allergy to ICG or iodine.
Pregnancy or breastfeeding.
High risk of choledocholithiasis (ESGE guidelines).
Thyroid disease.
Trial design
Treatments tested in this trial
- Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)
Treatment groups
Sponsors and collaborators
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