Clinical Trial: Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary: 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.
Sponsor: Ohio State University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Anatomic Identification With NIRF-C [ Time Frame: Intraoperative ]
    Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.
  • Time to Complete NIRF-C and IOC [ Time Frame: Intraoperative ]
    The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.


Original Secondary Outcome:

  • Incidence of Anatomic Identification With NIRF-C [ Time Frame: Intraoperative ]
    Incidence of anatomic identification with NIRF-C and intraoperative cholangiography will be used to calculate a 95% confidence interval for the effectiveness of this modality.
  • Time [ Time Frame: Intraoperative ]
    The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.


Information By: Ohio State University

Dates:
Date Received: February 21, 2014
Date Started: January 2013
Date Completion:
Last Updated: September 22, 2015
Last Verified: September 2015