Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion

Enrolling by invitation · Not applicable

Conditions studied: Ureteral Obstruction, Stricture Ureter

In brief

Ureteroenteric anastomotic stricture is a well-known complication of urinary diversion which occurs in 4-25% of patients. Recent study has yielded that radiation is a significant risk factor for development of ureteroenteric stricture. The goal of this study is to determine whether intraoperative use of SPY fluorescent angiography during urinary diversion reduces rate of ureteroenteric stricture. This study will include 215 patients who have undergone urinary diversion over the past 5 years as historic controls and compare ureteroenteric stricture rates to a prospective cohort of patients in whom intraoperative SPY fluorescent angiography was used at the time of urinary diversion to assess the anastomotic perfusion. This will include injection of ICG intravenously as well as utilization of the SPY device to assess ureteral perfusion before and after ureteroenteric anastomosis. Based on power analysis, this study will require approximately 50 patients in our prospective group to detect a clinically significant difference of 5% between groups. Data analysis plan includes the use of chi square test for comparison of stricture rates between groups. Clinical outcomes will be followed prospectively, with no amendment to standard follow-up per physician.

Key facts

Study ID
NCT05022199
Run by
University of Virginia
People needed
50
Starts
2021-03-01
Expected to finish
2023-07-01
Last updated by the study team
2021-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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Where it is running

Full record on ClinicalTrials.gov

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