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

The Ohio State University

Status and phase: Completed; Phase 1

Conditions: Acute Cholangitis; Acute Cholecystitis

Treatments: Device: Near Infrared Fluorescence Cholangiography (NIRF-C); Drug: Indocyanine Green (ICG)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02070627

2011H0239S

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

NIRF-C and IOC

Experimental group

Description:

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

Treatment:

Drug: Indocyanine Green (ICG)

Device: Near Infrared Fluorescence Cholangiography (NIRF-C)