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Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

NCT07400237 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Moisés Broggi de Sant Joan Despí, Barcelona

    collaborator UNKNOWN

  • Hospital Clínico Universitario de Valencia

    collaborator OTHER

  • Hospital Germans Tríes i Pujol de Badalona

    collaborator UNKNOWN

  • Hospital Joan XXIII, Tarragona

    collaborator UNKNOWN

  • Consorcio Parc de Salut Mar, Hospital del Mar

    collaborator UNKNOWN

  • Hospital Mutua de Terrassa

    collaborator OTHER

  • Consorci Sanitari Integral

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400237 on ClinicalTrials.gov