Intraoperative vs. Postoperative Intravesical Epirubicin Instillation for Prevention of Bladder Recurrence in High-Risk Upper Urinary Tract Urothelial Carcinoma

NCT ID: NCT06941038

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-06-20

Brief Summary

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Upper urinary tract urothelial carcinoma (UTUC) accounts for 5%-10% of urothelial malignancies, with up to 50% of patients developing bladder recurrence post-RNU. High-risk UTUC (≥pT2, high-grade, or N+ disease) necessitates aggressive management. Intravesical chemotherapy mitigates recurrence risk, yet optimal timing-intraoperative vs. postoperative-remains unclear. This study evaluates intraoperative epirubicin instillation during RNU compared to postoperative administration and no instillation.

Detailed Description

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Conditions

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Bladder Cancer Recurrence Intravesical Instillation Upper Urinary Tract Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* primary high-risk UTUC.

Exclusion Criteria

* prior bladder cancer,
* low-risk UTUC (managed conservatively),
* metastatic disease,
* incomplete follow-up
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Cagri Akpinar

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital Bilkent, Ankara, Ankara 06800

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E2-21-421

Identifier Type: -

Identifier Source: org_study_id

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