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

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.

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Key information

Conditions

Bladder Cancer Recurrence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intravesical Instillation Male Urogenital Diseases Neoplasms Neoplasms by Site Upper Urinary Tract Carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital Bilkent, Ankara, Ankara 06800

Ankara, 06050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

primary high-risk UTUC.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

To evaluate the relationship between intravesical chemotherapy administered intraoperatively or postoperatively and bladder recurrence.

Time frame: 365 days from the first instillation

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Effect of Intravesical Chemotherapy on Disease Recurrence in Patients Undergoing Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma

Acronym: IEPBR

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Apr 23, 2025
Registry last updated: Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed