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

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

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

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.

Detailed Summary:
Sponsor: Ohio State University

Current Primary Outcome:

• 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.
• 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.
• Procedure time [ Time Frame: Intraoperative ]
  The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: February 21, 2014
Date Started: July 2013
Date Completion:
Last Updated: October 30, 2014
Last Verified: October 2014