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

Phase 1

Completed

• Conditions: Acute Cholecystitis; Acute Cholangitis
• Interventions: Drug: Indocyanine Green (ICG); Device: Near Infrared Fluorescence Cholangiography (NIRF-C)

• Registration Number: NCT02070627
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIRF-C and IOC	Indocyanine Green (ICG)	Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.
NIRF-C and IOC	Near Infrared Fluorescence Cholangiography (NIRF-C)	Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography.

Primary Outcome Measures

Name	Time	Method
Adverse events related to use of indocyanine green (ICG)	Injection to 2 wk follow-up	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.
Procedure time	Intraoperative	The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared.
Anatomic identification with NIRF-C and IOC	Intraoperative	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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States