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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06941038

Acronym

IEPBR

Enrollment

270

Registered

2025-04-23

Start date

2021-06-01

Completion date

2024-06-20

Last updated

2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer Recurrence, Intravesical Instillation, Upper Urinary Tract Carcinoma

Keywords

bladder cancer, bladder cancer recurrence, intravesical instillation, upper urinary tract carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* primary high-risk UTUC.

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results