Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
Primary Purpose
Ureteral Obstruction, Stricture Ureter
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPY fluorescent angiography
Sponsored by
About this trial
This is an interventional prevention trial for Ureteral Obstruction
Eligibility Criteria
Inclusion Criteria:
- Undergoing open urinary diversion
Exclusion Criteria:
- Inability to provide informed consent
- Robotic-assisted urinary diversion
- Pregnant Women
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study Arm: SPY fluorescent angiography
Historic Control Arm: Urinary diversion without the use of SPY
Arm Description
This arm consists of 215 historic controls who have undergone urinary diversion at UVA from 2015-2020 without the use of SPY fluorescent angiography
Outcomes
Primary Outcome Measures
Incidence of Ureteroenteric Stricture
Secondary Outcome Measures
90 day postoperative readmission
Rate of hydronephrosis, pyelonephritis, or renal impairment
Full Information
NCT ID
NCT05022199
First Posted
August 23, 2021
Last Updated
August 23, 2021
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT05022199
Brief Title
Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
Official Title
Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Obstruction, Stricture Ureter
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Arm: SPY fluorescent angiography
Arm Type
Experimental
Arm Title
Historic Control Arm: Urinary diversion without the use of SPY
Arm Type
No Intervention
Arm Description
This arm consists of 215 historic controls who have undergone urinary diversion at UVA from 2015-2020 without the use of SPY fluorescent angiography
Intervention Type
Device
Intervention Name(s)
SPY fluorescent angiography
Intervention Description
This group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not.
Primary Outcome Measure Information:
Title
Incidence of Ureteroenteric Stricture
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
90 day postoperative readmission
Time Frame
90 days
Title
Rate of hydronephrosis, pyelonephritis, or renal impairment
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing open urinary diversion
Exclusion Criteria:
Inability to provide informed consent
Robotic-assisted urinary diversion
Pregnant Women
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31057669
Citation
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.
Results Reference
background
PubMed Identifier
30815976
Citation
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.
Results Reference
background
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Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
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