RecruitingNCT05731622

Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC

Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter Study


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

100 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC). The main question it aims to answer are: * What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC * How is the IVR compared with a historical cohort (no SI-MMC) * What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU) * What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • All patients suspect for having non-metastatic disease and planned for ureteroscopy (diagnostic or treatment) and adjuvant single instillation of Mitomycin C
  • Age ≥18 years
  • Written informed consent

Exclusion Criteria6

  • History of histological proven urothelial carcinoma of the bladder, including carcinoma in situ
  • History of histological proven UTUC in the contralateral kidney
  • Concurrent bladder tumour found pre-operatively or per-operatively
  • Patients where it is not feasible to obtain histology by biopsies intra-operatively
  • Known Mitomycin C
  • Renal transplantation

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Locations(1)

AmsterdamUMC

Amsterdam, Netherlands

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NCT05731622


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