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

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ClinicalTrials.gov Identifier: NCT02070640
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Collaborators:
Stryker Instruments
Society of American Gastrointestinal and Endoscopic Surgeons
Information provided by (Responsible Party):
Narula, Vimal K, MD, Ohio State University

Study Description
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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). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Condition or disease Intervention/treatment Phase
Cholecystitis Drug: Injection of indocyanine green (ICG) Device: Near Infrared Cholangiography Fluorescence (NIRF-C) Not Applicable

Detailed Description:
This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Near Infrared Fluorescence Cholangiography During Cholecystectomy
Study Start Date : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NIRF-C
Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.
 Drug: Injection of indocyanine green (ICG)
2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.

Device: Near Infrared Cholangiography Fluorescence (NIRF-C)
These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Other Names:
  • Stryker 1488 Camera System
  • Stryker L9000 Light Source
  • Stryker 1488 Coupler
  • Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)


Outcome Measures
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Primary Outcome Measures :
  1. Complications Related to ICG [ Time Frame: From time of injection to 1st post-op follow-up ]
    A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.


Secondary Outcome Measures :
  1. Incidence of Anatomic Identification With NIRF-C [ Time Frame: Intraoperative ]
    Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.

  2. Time to Complete NIRF-C and IOC [ Time Frame: Intraoperative ]
    The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-89
  • Planned laparoscopic cholecystectomy

Exclusion Criteria:

  • Inability to provide informed consent
  • Pregnant
  • Allergy to ICG, iodine, and/or shellfish
  • Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
  • Lactating
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070640


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
Ohio State University
Stryker Instruments
Society of American Gastrointestinal and Endoscopic Surgeons
Investigators
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Principal Investigator: Vimal K Narula, MD Ohio State University
More Information
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Responsible Party: Narula, Vimal K, MD, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02070640    
Other Study ID Numbers: 2011H0239
First Posted: February 25, 2014    Key Record Dates
Results First Posted: October 21, 2015
Last Update Posted: October 21, 2015
Last Verified: September 2015
Keywords provided by Narula, Vimal K, MD, Ohio State University:
cholecystectomy
cholecystitis
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases