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The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.
Sponsor: University Health Network, Toronto
Summary
This is an interventional pilot study aimed to evaluate the use of NIF imaging as an intraoperative aid to assess the anastomotic blood flow to the gastric pouch and gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term impact on the rate of marginal ulceration, leaks and stricture.
Official title: The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-01-25
Completion Date
2027-07-03
Last Updated
2025-10-16
Healthy Volunteers
No
Conditions
Interventions
Indocyanine green
Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.
Stryker 1688 AIM system
The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.
Locations (1)
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada