Comparing laparoscopic ultrasound and fluorescence imaging with indocyanine green to map bile ducts during difficult laparoscopic gallbladder removal
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
This will try two imaging methods—laparoscopic ultrasound and fluorescence cholangiography with indocyanine green—in adults having technically difficult laparoscopic gallbladder removal to see which shows the bile duct anatomy best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari Integral Academic / other |
| Locations | 1 site (Sant Joan Despí, Barcelona) |
| Trial ID | NCT07400237 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective interventional study in which each participant will receive both laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) during the same operation to allow direct within-patient comparison. LUS is performed first, followed by ICG fluorescence imaging prior to dissection of Calot's triangle using a standardized sequence. The primary endpoint is successful identification of the critical junction; secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, and intra- and postoperative complications. The trial focuses on cases anticipated to be technically difficult, such as acute cholecystitis, prior upper abdominal surgery, prior biliary disease, or obesity.
Who should consider this trial
Good fit: Adults (age ≥18) scheduled for laparoscopic cholecystectomy who are expected to have technical difficulty (for example acute cholecystitis, prior upper abdominal surgery, previous biliary interventions, or BMI ≥30) and who can give informed consent are ideal candidates.
Not a fit: People with known allergy to ICG or iodine, pregnancy or breastfeeding, high risk of common bile duct stones, thyroid disease, suspected gallbladder cancer, ASA class IV–V, advanced chronic kidney disease, or those planned for open cholecystectomy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, better intraoperative imaging could lower the risk of bile duct injury and improve safety during difficult gallbladder operations.
How similar studies have performed: Both laparoscopic ultrasound and ICG fluorescence have been used successfully to visualize biliary anatomy in prior series, but direct head-to-head comparisons in technically challenging cases are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Written informed consent provided. 3. 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). Exclusion Criteria: 1. Known allergy to ICG or iodine. 2. Pregnancy or breastfeeding. 3. High risk of choledocholithiasis (ESGE guidelines). 4. Thyroid disease. 5. Suspected gallbladder malignancy. 6. ASA class IV-V. 7. Chronic kidney disease stage \> IIIb. 8. Planned open cholecystectomy.
Where this trial is running
Sant Joan Despí, Barcelona
- Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral — Sant Joan Despí, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Andrea Sanz LLorente, M.D.
- Email: andreasanz@uic.es
- Phone: +34 93 5531200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.