Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cholecystectomy
• Intervention / Treatment: Diagnostic test: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Sanz LLorente, M.D.; Phone Number: +34 93 5531200; Email: andreasanz@uic.es
• Study Contact Backup: Name: Sergio González Martínez, M.D., Ph.D.; Email: sergio.gonzalez@csi.cat

Study Locations

• Spain
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Recruiting
      • Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
      • Contact: Andrea Sanz Llorente, M.D.; Phone Number: +34 935531200; Email: andreasanz@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Complex laparoscopic cholecystectomy; Laparoscopic cholecystectomy with anticipated technical difficulty

Diagnostic test: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG); Two intraoperative imaging modalities will be applied: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct	This intraoperative visualization will be assessed separately for laparoscopic ultrasound (LUS) and indocyanine green fluorescence cholangiography (ICG) and recorded as a binary outcome (yes/no) for each technique in each patient using a standardized intraoperative assessment form completed by the operating surgeon. Laparoscopic ultrasound will be performed first, followed by indocyanine green fluorescence cholangiography, according to a predefined and standardized intraoperative sequence. Intraoperative photographic documentation will be obtained for each imaging modality to objectively demonstrate the visualization of the critical biliary junction. Results will be reported as the proportion of patients with successful visualization for each modality and compared using an intra-subject analysis.	Intraoperative

Collaborators and Investigators

• Sponsor: Consorci Sanitari Integral
• Collaborators: Hospital Mutua de Terrassa; Hospital Moisés Broggi de Sant Joan Despí, Barcelona; Hospital Clínico Universitario de Valencia; Hospital Germans Tríes i Pujol de Badalona; Consorcio Parc de Salut Mar, Hospital del Mar; Hospital Joan XXIII, Tarragona

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: indocyanine green; laparoscopic cholecystectomy; laparoscopic ultrasound; fluorescence cholangiography; biliary injury prevention
• Other Study ID Numbers: 24/49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No