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

NCT05022199 | Enrolling By Invitation FDA Device

• 1 other identifier: HSR200414
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Obstruction; Stricture Ureter

Outcome Measures

Primary Outcomes (1)

• Incidence of Ureteroenteric Stricture

  1.5 years

Secondary Outcomes (2)

• 90 day postoperative readmission

  90 days

• Rate of hydronephrosis, pyelonephritis, or renal impairment

  90 days

Study Arms (2)

Study Arm: SPY fluorescent angiography

EXPERIMENTAL

Device: SPY fluorescent angiography

Historic Control Arm: Urinary diversion without the use of SPY

NO INTERVENTION

This arm consists of 215 historic controls who have undergone urinary diversion at UVA from 2015-2020 without the use of SPY fluorescent angiography

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 Arm: SPY fluorescent angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing open urinary diversion

You may not qualify if:

• Inability to provide informed consent
• Robotic-assisted urinary diversion
• Pregnant Women

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

Location

Related Publications (3)

• Shen JK, Jamnagerwalla J, Yuh BE, Bassett MR, Chenam A, Warner JN, Zhumkhawala A, Yamzon JL, Whelan C, Ruel NH, Lau CS, Chan KG. Real-time indocyanine green angiography with the SPY fluorescence imaging platform decreases benign ureteroenteric strictures in urinary diversions performed during radical cystectomy. Ther Adv Urol. 2019 Apr 4;11:1756287219839631. doi: 10.1177/1756287219839631. eCollection 2019 Jan-Dec.

  PMID: 31057669 BACKGROUND

• Ahmadi N, Ashrafi AN, Hartman N, Shakir A, Cacciamani GE, Freitas D, Rajarubendra N, Fay C, Berger A, Desai MM, Gill IS, Aron M. Use of indocyanine green to minimise uretero-enteric strictures after robotic radical cystectomy. BJU Int. 2019 Aug;124(2):302-307. doi: 10.1111/bju.14733. Epub 2019 Apr 11.

  PMID: 30815976 BACKGROUND

• Yeaman C, Ignozzi G, Kazeem A, Isharwal S, Krupski TL, Culp SH. Impact of SPY Fluorescence Angiography on Incidence of Ureteroenteric Stricture After Urinary Diversion. J Urol. 2024 Dec;212(6):844-850. doi: 10.1097/JU.0000000000004198. Epub 2024 Aug 20.

  PMID: 39162209 DERIVED

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Urology

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 26, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2023
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)