Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

NCT07400237 | Recruiting

• 1 other identifier: 24/49
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystectomy

Keywords

laparoscopic cholecystectomy; laparoscopic ultrasound; fluorescence cholangiography; indocyanine green; biliary injury prevention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Complex laparoscopic cholecystectomy

OTHER

Laparoscopic cholecystectomy with anticipated technical difficulty

Diagnostic Test: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)

Interventions

Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) DIAGNOSTIC_TEST

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.

Complex laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Known allergy to ICG or iodine.
• Pregnancy or breastfeeding.
• High risk of choledocholithiasis (ESGE guidelines).
• Thyroid disease.
• Suspected gallbladder malignancy.
• ASA class IV-V.
• Chronic kidney disease stage \> IIIb.
• Planned open cholecystectomy.

Sponsors & Collaborators

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

Study Sites (1)

Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Central Study Contacts

Andrea Sanz LLorente, M.D.

CONTACT

+34 93 5531200; andreasanz@uic.es

Sergio González Martínez, M.D., Ph.D.

CONTACT

sergio.gonzalez@csi.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 10, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)