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Recruiting NCT07400237

Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

No phase Interventional Cholecystectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG).
Who it may be relevant to
Registry conditions: Cholecystectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 triangl

Primary outcome measures

  • Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct [Time frame: Intraoperative]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Spain · 1 center
  • Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral — Sant Joan Despí

Identifiers

NCT: NCT07400237 · 24/49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗