Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

Brief Title

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

Official Title

Near Infrared Fluorescence Cholangiography During Cholecystectomy

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.
    

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 Type

Interventional

Primary Outcome

Complications Related to ICG

Secondary Outcome

 Incidence of Anatomic Identification With NIRF-C

Condition

Cholecystitis

Intervention

Injection of indocyanine green (ICG)

Study Arms / Comparison Groups

 NIRF-C

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

99

Start Date

January 2013

Completion Date

August 2014

Primary Completion Date

August 2014

Eligibility 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
      

Gender

All

Ages

18 Years - 89 Years

Accepts Healthy Volunteers

No

Contacts

Vimal K Narula, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02070640

Organization ID

2011H0239

Responsible Party

Principal Investigator

Study Sponsor

Ohio State University

Collaborators

 Stryker Instruments

Study Sponsor

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

Verification Date

September 2015