Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

NCT02070640 | Completed Results

• 1 other identifier: 2011H0239
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis

Keywords

cholecystectomy; cholecystitis

Outcome Measures

Primary Outcomes (1)

• Complications Related to ICG

  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.

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

Secondary Outcomes (2)

• Incidence of Anatomic Identification With NIRF-C

  Intraoperative

• Time to Complete NIRF-C and IOC

  Intraoperative

Study Arms (1)

NIRF-C

EXPERIMENTAL

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.

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

Interventions

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.

NIRF-C

Near Infrared Cholangiography Fluorescence (NIRF-C) DEVICE

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

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

NIRF-C

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89
• Planned laparoscopic cholecystectomy

You may not qualify if:

• Inability to provide informed consent
• Pregnant
• Allergy to ICG, iodine, and/or shellfish
• Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
• Lactating

Sponsors & Collaborators

• Ohio State University: lead
• Stryker Instruments: collaborator
• Society of American Gastrointestinal and Endoscopic Surgeons: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Results Point of Contact

• Title: Associate Professor
• Organization: The Ohio State University Wexner Medical Center

raaja.narula@osumc.edu

614-293-3230

Study Officials

• Vimal K Narula, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 21, 2015
• Results First Posted: October 21, 2015

Record last verified: 2015-09

Locations

US (1)