Actively Recruiting
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
Led by Consorci Sanitari Integral · Updated on 2026-02-10
62
Participants Needed
1
Research Sites
52 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
Researchers are evaluating two imaging methods, laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), to identify biliary anatomy during technically challenging laparoscopic gallbladder removal surgery. This multicenter, prospective, interventional clinical trial aims to compare the success of these techniques in detecting critical junctions of bile ducts, which is important for patient safety during surgery. Participants will undergo both imaging tests during their gallbladder surgery in a set order: first LUS, then fluorescence cholangiography before the key surgical dissection. This allows direct comparison of the two methods within the same procedure. The study focuses on patients who have anticipated surgical difficulty due to conditions like acute cholecystitis, prior abdominal surgeries, or obesity. During the study, researchers will monitor how clearly each imaging method identifies important bile duct junctions, how long it takes to visualize these structures, total surgery time, and any complications during or after surgery. The study also involves tracking patient outcomes intraoperatively and postoperatively to assess safety and effectiveness. Participation begins with surgery and includes follow-up for these measures.
CONDITIONS
Brief Title
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent provided
- Scheduled for laparoscopic gallbladder removal surgery with expected technical difficulty due to acute cholecystitis, previous cholangitis, pancreatitis, ERCP, prior upper abdominal surgery, or obesity (BMI ≥ 30 kg/m²)
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 physical status class IV or V
- Chronic kidney disease stage greater than IIIb
- Planned open gallbladder removal surgery instead of laparoscopic
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
During the laparoscopic gallbladder removal surgery, participants undergo two intraoperative imaging tests — laparoscopic ultrasound (LUS) followed by fluorescence cholangiography with indocyanine green (ICG) — to identify biliary anatomy.
1 surgical visit (in-person)
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.
S
Sergio González Martínez, M.D., Ph.D.
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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