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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
UTUC treatment
UTUC treatment
Assuta Ashdod Hospital
Ashdod, Israel
RECRUITINGSoroka University Medical Center
Beersheba, Israel
RECRUITINGShamir Medical Center
Be’er Ya‘aqov, Israel
1 year IVR free survival
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
Time frame: 1 year
2 years IVR free survival
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year
Time frame: 2 years
Disease free survival
Time frame: 2 years
High grade (>3) adverse events
Adverse events that are severe or medically significant but not immediately life threatening
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bnai Zion Medical Center
Haifa, Israel
RECRUITINGCarmel Medical Center
Haifa, Israel
RECRUITINGRambam Health Care Campus
Haifa, Israel
RECRUITINGRabin Medical Center - Beilinson and Hasharon
Petah Tikva, Israel
RECRUITINGKaplan Medical Center
Rehovot, Israel
RECRUITINGZiv Medical Center
Safed, Israel
RECRUITINGTel Aviv Sourasky Medical Center - Ichilov
Tel Aviv, Israel
RECRUITING