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NCT Number: NCT07400237

Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral

Sant Joan Despí, Barcelona, 08970, Spain

Location status: Recruiting

Location contact

Andrea Sanz Llorente, M.D.

CONTACT

[email protected]

+34 935531200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct

    Time frame: Intraoperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Sanz LLorente, M.D.

CONTACT

[email protected]

+34 93 5531200

Sergio González Martínez, M.D., Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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