Brief Title
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
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 Description
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.
Study Type
Interventional
Primary Outcome
Complications Related to ICG
Secondary Outcome
Incidence of Anatomic Identification With NIRF-C
Condition
Cholecystitis
Intervention
Injection of indocyanine green (ICG)
Study Arms / Comparison Groups
NIRF-C
Description: Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.
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
99
Start Date
January 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 - Acute cholecystitis, cholangitis, and/or cirrhosis (main study) - 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
NCT02070640
Organization ID
2011H0239
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
September 2015