Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• Written informed consent provided.

• Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following:

‣ Acute cholecystitis.

⁃ Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography.

⁃ Prior upper abdominal surgery.

⁃ Obesity (Body Mass Index ≥ 30 kg/m²).

Locations
Other Locations
Spain
Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
RECRUITING
Sant Joan Despí
Contact Information
Primary
Andrea Sanz LLorente, M.D.
andreasanz@uic.es
+34 93 5531200
Backup
Sergio González Martínez, M.D., Ph.D.
sergio.gonzalez@csi.cat
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 62
Treatments
Other: Complex laparoscopic cholecystectomy
Laparoscopic cholecystectomy with anticipated technical difficulty
Related Therapeutic Areas
Sponsors
Leads: Consorci Sanitari Integral
Collaborators: Hospital Mutua de Terrassa, Consorcio Parc de Salut Mar, Hospital del Mar, Hospital Joan XXIII, Tarragona, Hospital Moisés Broggi de Sant Joan Despí, Barcelona, Hospital Clínico Universitario de Valencia, Hospital Germans Tríes i Pujol de Badalona

This content was sourced from clinicaltrials.gov