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

NCT02070627 | Completed Phase 1

• 1 other identifier: 2011H0239S
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis; Acute Cholangitis

Keywords

acute cholecystitis; acute cholangitis; cholecystectomy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Procedure time

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

  Intraoperative

Study Arms (1)

NIRF-C and IOC

EXPERIMENTAL

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); Device: Near Infrared Fluorescence Cholangiography (NIRF-C)

Interventions

Indocyanine Green (ICG) DRUG

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.

NIRF-C and IOC

Near Infrared Fluorescence Cholangiography (NIRF-C) DEVICE

Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.

Also known as: Stryker 1488 Camera System, Stryker L9000 Light Source, Stryker 1488 Coupler, Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)

NIRF-C and IOC

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89
• Planned laparoscopic cholecystectomy

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead
• Stryker Instruments: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vimal K Narula, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

US (1)