Cholecystitis
Conditions
Keywords
cholecystectomy, cholecystitis
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.
Detailed description
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.
Interventions
DRUGInjection of indocyanine green (ICG)
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.
DEVICENear Infrared Cholangiography Fluorescence (NIRF-C)
These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Sponsors
Stryker Instruments
Society of American Gastrointestinal and Endoscopic Surgeons
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications Related to ICG | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Anatomic Identification With NIRF-C | Intraoperative | Incidence of anatomic identification with NIRF-C and intraoperative cholangiography. |
| Time to Complete NIRF-C and IOC | Intraoperative | The time required to complete NIRF-C and intraoperative cholangiography will be analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| 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. | 6 |
| Total | 88 |
Baseline characteristics
| Characteristic | Non-Acute | Acute Cholecystitis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 6 Participants | 84 Participants |
| Region of Enrollment United States | 82 participants | 6 participants | 88 participants |
| Sex: Female, Male Female | 64 Participants | 3 Participants | 67 Participants |
| Sex: Female, Male Male | 18 Participants | 3 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 93 | 0 / 6 |
| serious Total, serious adverse events | 0 / 93 | 0 / 6 |
Outcome results
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.
Time frame: From time of injection to 1st post-op follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Acute | Complications Related to ICG | 0 % of Participants with Complications |
| Acute Cholecystitis | Complications Related to ICG | 0 % of Participants with Complications |
Secondary
Incidence of Anatomic Identification With NIRF-C
Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.
Time frame: Intraoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Acute | Incidence of Anatomic Identification With NIRF-C | 95.1 percentage of biliary anatomy observatio |
| Acute Cholecystitis | Incidence of Anatomic Identification With NIRF-C | 33 percentage of biliary anatomy observatio |
Secondary
Time to Complete NIRF-C and IOC
The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Acute | Time to Complete NIRF-C and IOC | 1.9 minutes |
| Acute Cholecystitis | Time to Complete NIRF-C and IOC | 1.08 minutes |