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

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT02070627
Collaborator
Stryker Instruments (Industry)
6
Enrollment
1
Location
1
Arm
13
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine Green (ICG)
  • Device: Near Infrared Fluorescence Cholangiography (NIRF-C)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: NIRF-C and IOC

Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.

Drug: Indocyanine Green (ICG)
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.

Device: Near Infrared Fluorescence Cholangiography (NIRF-C)
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)

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18-89

    • Planned laparoscopic cholecystectomy

    Exclusion Criteria:

    • Inability to provide informed consent

    • Pregnant

    • Allergy to ICG, iodine, and/or shellfish

    • Lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University
    • Stryker Instruments

    Investigators

    • Principal Investigator: Vimal K Narula, MD, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Narula, Vimal K, MD, Associate Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT02070627
    Other Study ID Numbers:
    • 2011H0239S
    First Posted:
    Feb 25, 2014
    Last Update Posted:
    Nov 2, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Narula, Vimal K, MD, Associate Professor, Ohio State University
    acute cholecystitis
    acute cholangitis
    cholecystectomy
    Additional relevant MeSH terms:
    Cholangitis
    Cholecystitis
    Acalculous Cholecystitis
    Cholecystitis, Acute

    Study Results

    No Results Posted as of Nov 2, 2014