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NCT02070627 Clinical Trial

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

Acute Cholecystitis Clinical Trial

— NIRF-C Acute  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02070627
Other study ID # 2011H0239S
Secondary ID
Status Completed
Phase Phase 1
First received February 21, 2014
Last updated October 30, 2014
Start date July 2013
Est. completion date August 2014

Study information
Verified date October 2014
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- Age 18-89

- Planned laparoscopic cholecystectomy

Exclusion Criteria:

- Inability to provide informed consent

- Pregnant

- Allergy to ICG, iodine, and/or shellfish

- Lactating

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University Stryker Instruments

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events related to use of indocyanine green (ICG) 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. Injection to 2 wk follow-up Yes
Primary Anatomic identification with NIRF-C and IOC 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. Intraoperative No
Primary Procedure time The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared. Intraoperative No
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