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

Primary Purpose

Acute Cholecystitis, Acute Cholangitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green (ICG)
Near Infrared Fluorescence Cholangiography (NIRF-C)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Cholecystitis focused on measuring acute cholecystitis, acute cholangitis, cholecystectomy

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-89
  • Planned laparoscopic cholecystectomy

Exclusion Criteria:

  • Inability to provide informed consent
  • Pregnant
  • Allergy to ICG, iodine, and/or shellfish
  • Lactating

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIRF-C and IOC

Arm Description

Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.

Outcomes

Primary Outcome Measures

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.
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.
Procedure time
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2014
Last Updated
October 30, 2014
Sponsor
Ohio State University
Collaborators
Stryker Instruments
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1. Study Identification

Unique Protocol Identification Number
NCT02070627
Brief Title
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study
Acronym
NIRF-C Acute
Official Title
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Stryker Instruments

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis, Acute Cholangitis
Keywords
acute cholecystitis, acute cholangitis, cholecystectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIRF-C and IOC
Arm Type
Experimental
Arm Description
Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green (ICG)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Near Infrared Fluorescence Cholangiography (NIRF-C)
Other Intervention Name(s)
Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)
Intervention Description
Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.
Primary Outcome Measure Information:
Title
Adverse events related to use of indocyanine green (ICG)
Description
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.
Time Frame
Injection to 2 wk follow-up
Title
Anatomic identification with NIRF-C and IOC
Description
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.
Time Frame
Intraoperative
Title
Procedure time
Description
The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vimal K Narula, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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