Ureteral ObstructionNCT05022199
Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
A study testing SPY fluorescent angiography in people with Ureteral Obstruction and Stricture Ureter, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Obstruction, Stricture Ureter
- What is being tested?
- SPY fluorescent angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Jul 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing open urinary diversion
Who cannot join
- Inability to provide informed consent
- Robotic-assisted urinary diversion
- Pregnant Women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22902
About this study
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.
Read the 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
- Being tested
- SPY fluorescent angiography
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY fluorescent angiographyDevice
This group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm: SPY fluorescent angiography | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ureteroenteric Stricture
Measured: 1.5 years
Secondary outcomes (2)
90 day postoperative readmission
Measured: 90 days
Rate of hydronephrosis, pyelonephritis, or renal impairment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Mar 2021
- Primary completionDec 2021 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey Krupski, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022199
- Sponsor's protocol ID
- HSR200414
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 31057669Ahmadi 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.
PubMed 30815976Yeaman 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.
PubMed 39162209
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
- ClinicalTrials.gov ID
- NCT05022199
- Acronym / sponsor ID
- HSR200414
- Conditions
- Ureteral Obstruction, Stricture Ureter
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing open urinary diversion
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Robotic-assisted urinary diversion
- Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPY fluorescent angiographyThis group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not. | Device | Study Arm: SPY fluorescent angiography |
Primary outcome
Incidence of Ureteroenteric Stricture
Time frame: 1.5 years
2 secondary outcomes
90 day postoperative readmission
Time frame: 90 days
Rate of hydronephrosis, pyelonephritis, or renal impairment
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Background: PubMed 31057669Shen 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.
- Background: PubMed 30815976Ahmadi 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.
- Derived from this study: PubMed 39162209Yeaman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPY fluorescent angiography in people with Ureteral Obstruction and Stricture Ureter, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ureteroenteric Stricture (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022199, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.