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Completed

NCT Number: NCT02070640

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

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.

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of indocyanine green (ICG)

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)

Device

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

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

Primary outcomes

  1. Complications Related to ICG

    Time frame: From time of injection to 1st post-op follow-up

    A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.

Secondary outcomes

  1. Incidence of Anatomic Identification With NIRF-C

    Time frame: Intraoperative

    Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.

  2. Time to Complete NIRF-C and IOC

    Time frame: Intraoperative

    The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Society of American Gastrointestinal and Endoscopic Surgeons
  • Stryker Instruments

Registry information

Official study title

Near Infrared Fluorescence Cholangiography During Cholecystectomy

Acronym: NIRF-C

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2014
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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