Start Date
June 1, 2017
Primary Completion Date
January 23, 2018
Study Completion Date
January 23, 2018
Order of two elements of surgical procedure
Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.
Indocyanine Green
Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
Lead Sponsor
Duke University
OTHER