Brief Title
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Adverse events related to use of indocyanine green (ICG)
Condition
Acute Cholecystitis
Intervention
Indocyanine Green (ICG)
Study Arms / Comparison Groups
NIRF-C and IOC
Description: Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
July 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
- 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
Administrative Informations
NCT ID
NCT02070627
Organization ID
2011H0239S
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
October 2014