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POST URS Chemotherapy Instillation

POST URS Chemotherapy Instillation

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR.

Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.

Description

URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function.

Following extirpative surgery patients are prone to IVR. Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols. In this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU.

Retrospective evidence suggests there is an increase IVR rates following URS for UTUC.

In this study the investigators seek to evaluate the efficacy of a single, post URS, bladder instillation with chemotherapy to reduce IVR.

Eligibility

Inclusion Criteria:

  • Radiographic and/or cytological suspicion for UTUC
  • Planned endoscopic procedure for treatment / diagnosis of UTUC
  • Patients with bladder cancer history are eligible if meeting both following criteria:

No recurrence within the last two years Are not on active bladder irrigation protocol

  • Patients with history of UTUC are eligible if last endoscopic treatment or RNU was >1 year prior to enrollment
  • Age ≥ 18 years
  • Performance status ECOG 0-2

Exclusion Criteria:

  • Subjects who have had bladder / prostate radiotherapy
  • Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment
  • Subjects with previously treated UTUC within one year prior to enrollment
  • Subjects with metastatic disease

Study details
    UTUC

NCT06167057

Carmel Medical Center

26 January 2024

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