Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Near Infrared Fluorescence Cholangiography During Cholecystectomy

Conditions
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Cholecystitis

Intervention / Treatment
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* Drug: Injection of indocyanine green (ICG)
* Device: Near Infrared Cholangiography Fluorescence (NIRF-C)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRF-C<br>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)<br>* 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.<br>Device: Near Infrared Cholangiography Fluorescence (NIRF-C)<br>* These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.<br>* Other names: Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Anatomic Identification With NIRF-C | Incidence of anatomic identification with NIRF-C and intraoperative cholangiography. | Intraoperative | 
| Time to Complete NIRF-C and IOC | The time required to complete NIRF-C and intraoperative cholangiography will be analyzed. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy, cholecystitis