Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

The Ohio State University

Status: Completed

Conditions: Cholecystitis

Treatments: Device: Near Infrared Cholangiography Fluorescence (NIRF-C); Drug: Injection of indocyanine green (ICG)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02070640

2011H0239

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). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Full description

This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.

Enrollment: 99 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
• Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
• Lactating

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

NIRF-C

Experimental group

Description:

Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.

Treatment:

Device: Near Infrared Cholangiography Fluorescence (NIRF-C)

Drug: Injection of indocyanine green (ICG)