Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study

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) in patients with acute cholecystitis and cholangitis. We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Official Title
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Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Sub-Study

Conditions
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Acute Cholecystitis, Acute Cholangitis

Intervention / Treatment
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* Drug: Indocyanine Green (ICG)
* Device: Near Infrared Fluorescence Cholangiography (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 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 and IOC<br>Each enrolled subject will undergo injection with indocyanine green (ICG), intraoperative near infrared fluorescence cholangiography (NIRF-C) and standard of care intraoperative cholangiography. | Drug: Indocyanine Green (ICG)<br>* 60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.<br>Device: Near Infrared Fluorescence Cholangiography (NIRF-C)<br>* Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.<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 |
| --- | --- | --- |
| Adverse events related to use of indocyanine green (ICG) | Adverse events related to the use of ICG from the time of injection through the initial post-operative clinic visit will be recorded and assessed. | Injection to 2 wk follow-up | 
| Anatomic identification with NIRF-C and IOC | Anatomic identification with near-infrared fluorescence cholangiography and standard of care intraoperative cholangiography (IOC) will be used to calculate a 95% confidence interval for the effectiveness of this modality. | Intraoperative | 
| Procedure time | The time it takes to perform near infrared fluorescence cholangiography and standard of care intraoperative cholangiography will be compared. | Intraoperative | 

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