Actively Recruiting
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy
Led by Consorci Sanitari Integral · Updated on 2026-02-10
62
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
C
Consorci Sanitari Integral
Lead Sponsor
H
Hospital Moisés Broggi de Sant Joan Despí, Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years or older
- Provided written informed consent
- Scheduled for laparoscopic cholecystectomy with expected technical difficulty due to acute cholecystitis, previous cholangitis, pancreatitis, endoscopic retrograde cholangiopancreatography, prior upper abdominal surgery, or obesity (BMI 230 kg/m�B2)
You will not qualify if you...
- Known allergy to indocyanine green (ICG) or iodine
- Pregnancy or breastfeeding
- High risk of choledocholithiasis according to ESGE guidelines
- Thyroid disease
- Suspected gallbladder cancer
- ASA class IV or V
- Chronic kidney disease stage higher than IIIb
- Planned open cholecystectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Sant Joan Despí, Barcelona, Spain, 08970
Actively Recruiting
Research Team
A
Andrea Sanz LLorente, M.D.
CONTACT
S
Sergio González Martínez, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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