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

Completed

• Conditions: Bladder Cancer Recurrence; Intravesical Instillation; Upper Urinary Tract Carcinoma

• Registration Number: NCT06941038
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-20
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• primary high-risk UTUC.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the relationship between intravesical chemotherapy administered intraoperatively or postoperatively and bladder recurrence.	365 days from the first instillation

Trial Locations

Locations (1)

Ankara City Hospital Bilkent, Ankara, Ankara 06800; 🇹🇷 Ankara, Turkey