Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

NCT ID: NCT02070640

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-08-31

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

Detailed 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.

Conditions

Cholecystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NIRF-C

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.

Group Type: EXPERIMENTAL

Injection of indocyanine green (ICG)

Intervention Type: DRUG

2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.

Near Infrared Cholangiography Fluorescence (NIRF-C)

Intervention Type: DEVICE

These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.

Interventions

Injection of indocyanine green (ICG)

2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.

Intervention Type: DRUG

Near Infrared Cholangiography Fluorescence (NIRF-C)

These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.

Intervention Type: DEVICE

Other Intervention Names

Stryker 1488 Camera System; Stryker L9000 Light Source; Stryker 1488 Coupler; Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Instruments

INDUSTRY

Sponsor Role: collaborator

Society of American Gastrointestinal and Endoscopic Surgeons

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Narula, Vimal K, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vimal K Narula, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2011H0239

Identifier Type: -

Identifier Source: org_study_id