Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study (NIRF-C Acute)
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|ClinicalTrials.gov Identifier: NCT02070627|
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : November 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Cholecystitis Acute Cholangitis||Drug: Indocyanine Green (ICG) Device: Near Infrared Fluorescence Cholangiography (NIRF-C)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
- 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.
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): NCT02070627
|United States, Ohio|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Vimal K Narula, MD||Ohio State University|