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

Conditions

• Stricture Ureter
• Ureteral Obstruction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SPY fluorescent angiography — DEVICE
  This group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not.

Study Details

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 Dates

Start date

Mar 1, 2021

Status verified

Aug 2021

Primary completion

Dec 31, 2021

Completion

Jul 31, 2023

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Study Arm: SPY fluorescent angiography
• No Intervention: Historic Control Arm: Urinary diversion without the use of SPY
  This arm consists of 215 historic controls who have undergone urinary diversion at UVA from 2015-2020 without the use of SPY fluorescent angiography

Primary Outcome Measure

Incidence of Ureteroenteric Stricture [ Time Frame: 1.5 years ]

Locations (1)

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