Mitomycin/Gemcitabine
DrugUTUC treatment
NCT Number: NCT06167057
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Assuta Ashdod Hospital, Ashdod, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
No recurrence within the last two years Are not on active bladder irrigation protocol
Exclusion criteria
UTUC treatment
UTUC treatment
Time frame: 1 year
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
Time frame: 2 years
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year
Time frame: 2 years
Time frame: 2 years
Adverse events that are severe or medically significant but not immediately life threatening
Contact information is provided by the study sponsor or research team.
Carmel Medical Center
Other
Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
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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.
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