Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorci Sanitari Integral

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

62 Participants
are divided into 1 treatment group

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