Trial record 17 of 30 for:    Open Studies | "Cholangitis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ohio State University
Sponsor:
Collaborator:
Stryker Instruments
Information provided by (Responsible Party):
Narula, Vimal K, MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT02070627
First received: February 21, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Acute Cholecystitis
Acute Cholangitis
Drug: Indocyanine Green (ICG)
Device: Near Infrared Fluorescence Cholangiography (NIRF-C)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Adverse events related to use of indocyanine green (ICG) [ Time Frame: Injection to 2 wk follow-up ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Stryker 1488 Camera System
  • Stryker L9000 Light Source
  • Stryker 1488 Coupler
  • Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070627

Contacts
Contact: Rebecca Dettorre, MA 614-293-8549 becky.dettorre@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Dettorre, MA    614-293-8549    becky.dettorre@osumc.edu   
Principal Investigator: Vimal K Narula, MD         
Sponsors and Collaborators
Ohio State University
Stryker Instruments
Investigators
Principal Investigator: Vimal K Narula, MD Ohio State University
  More Information

No publications provided

Responsible Party: Narula, Vimal K, MD, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02070627     History of Changes
Other Study ID Numbers: 2011H0239S
Study First Received: February 21, 2014
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
acute cholecystitis
acute cholangitis
cholecystectomy

Additional relevant MeSH terms:
Cholangitis
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on August 28, 2014