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

NCT ID: NCT05022199

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-07-31

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.

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.

Conditions

Ureteral Obstruction; Stricture Ureter

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Arm: SPY fluorescent angiography

Group Type: EXPERIMENTAL

SPY fluorescent angiography

Intervention Type: DEVICE

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SPY fluorescent angiography

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Undergoing open urinary diversion

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Tracey Krupski, MD

Associate Professor, Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31057669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30815976 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39162209 (View on PubMed)

Other Identifiers

HSR200414

Identifier Type: -

Identifier Source: org_study_id