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| Name | Class |
|---|---|
| Stryker Instruments | INDUSTRY |
| Society of American Gastrointestinal and Endoscopic Surgeons | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vimal K Narula, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43214 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-acute | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
| FG001 | Acute Cholecystitis | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cholecystitis or acute cholecystitis
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Acute | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | % of Participants with Complications | From time of injection to 1st post-op follow-up |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-acute | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV infiltration of ICG | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor | The Ohio State University Wexner Medical Center | 614-293-3230 | raaja.narula@osumc.edu |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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|
| Near Infrared Cholangiography Fluorescence (NIRF-C) | Device | These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
|
|
| Intraoperative |
| BG001 | Acute Cholecystitis | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Acute Cholecystitis |
Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. |
|
|
| Secondary | Incidence of Anatomic Identification With NIRF-C | Incidence of anatomic identification with NIRF-C and intraoperative cholangiography. | Posted | Number | percentage of biliary anatomy observatio | Intraoperative |
|
|
|
| Secondary | Time to Complete NIRF-C and IOC | The time required to complete NIRF-C and intraoperative cholangiography will be analyzed. | Posted | Mean | Full Range | minutes | Intraoperative |
|
|
|
| 0 |
| 93 |
| 1 |
| 93 |
| EG001 | Acute Cholecystitis | Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. 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): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce. | 0 | 6 | 0 | 6 |
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