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Completed

NCT Number: NCT02070627

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study

The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

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Key information

Conditions

Acute Cholecystitis Acute Cholangitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-89
  • Planned laparoscopic cholecystectomy

Exclusion criteria

  • Inability to provide informed consent
  • Pregnant
  • Allergy to ICG, iodine, and/or shellfish
  • Lactating

Treatment and study plan

Indocyanine Green (ICG)

Drug

60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.

Near Infrared Fluorescence Cholangiography (NIRF-C)

Device

Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.

Other names: Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)

Primary outcomes

  1. Adverse events related to use of indocyanine green (ICG)

    Time frame: Injection to 2 wk follow-up

    Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed.

  2. Anatomic identification with NIRF-C and IOC

    Time frame: Intraoperative

    Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality.

  3. Procedure time

    Time frame: Intraoperative

    The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Stryker Instruments

Registry information

Official study title

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study

Acronym: NIRF-C Acute

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2014
Registry last updated
Nov 3, 2014

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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