Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study (NIRF-C Acute)
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.
Drug: Indocyanine Green (ICG)
Device: Near Infrared Fluorescence Cholangiography (NIRF-C)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study|
- Adverse events related to use of indocyanine green (ICG) [ Time Frame: Injection to 2 wk follow-up ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02070627
|Contact: Rebecca Dettorre, MAfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Rebecca Dettorre, MA 614-293-8549 email@example.com|
|Principal Investigator: Vimal K Narula, MD|
|Principal Investigator:||Vimal K Narula, MD||Ohio State University|