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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ureteral Obstruction; Stricture Ureter
• Intervention / Treatment: Device: SPY fluorescent angiography

Detailed Description

Ureteroenteric anastomotic stricture is a well-known complication of urinary diversion which occurs in 4-25% of patients. Strictures present clinically with flank pain, decreased renal function, pyelonephritis or may be asymptomatic and diagnosed incidentally with progressive hydronephrosis and renal impairment. Strictures are a cause of significant morbidity and health care expenditure, as treatment necessitates procedural intervention and often several inpatient admissions. Numerous studies have sought to identify risk factors for development of ureteroenteric strictures as well as opportunities for technical approaches to reduce stricture risk. Studies have demonstrated that Clavien-Dindo ≥ 3 complication and BMI were associated with higher risk of stricture.

Ischemia of the anastomosis related to the tenuous ureteral blood supply is implicated in the formation of ureteroenteric stricture. Basic science and animal data have established the detrimental impact of radiation therapy on microvasculature. Radiation induced ureteral ischemia in conjunction with periureteral fibrosis make preservation of distal ureteral blood supply during urinary diversion tenuous and challenging. This is especially of concern in patients requiring pelvic exenteration for colorectal or gynecological malignancy, which often necessitate radiation therapy prior to surgical intervention. Radiation history is also an important contributor commonly in patients undergoing benign diversion for radiation cystitis.

Several groups have tested whether varied surgical methods may offer risk reduction. Surgical anastomotic approach has not significantly impacted ureteroenteric stricture rate. However, a more recent study suggests that intracorporeal diversion confers a higher risk of ureteroenteric stricture. The gold standard for treatment of ureteroenteric stricture is open repair with ureteral reimplantation. Open surgical repair has success of 92-100%, while endoscopic management has success of 30-50%.

A recent study demonstrated that through the use of indocyanine green (ICG) fluorescent angiography while performing urinary diversion using the DaVinci robotic system, that they were able to reduce stricture rates from 10.6% to 0%. Use of this technology allows the surgeon to evaluate the vascular supply to the ureter as well as the newly created ureteroenteric anastomosis. This significant reduction in complications has tremendous implications for improvement in patient care and reduction of morbidity. Many patients are not candidates for robotic urinary diversion and thus undergo open surgery. Fluorescent angiography has also shown promise for decreasing ureteroenteric stricture rate in open surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undergoing open urinary diversion

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Arm: SPY fluorescent angiography	Device: SPY fluorescent angiography; This group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Ureteroenteric Stricture	1.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
90 day postoperative readmission	90 days
Rate of hydronephrosis, pyelonephritis, or renal impairment	90 days

Collaborators and Investigators

• Sponsor: University of Virginia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Constriction, Pathologic; Ureteral Obstruction
• Other Study ID Numbers: HSR200414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No