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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation |
|
| B | Placebo Comparator | Single post-operative 50cc Saline 0.9% bladder instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin/Gemcitabine | Drug | UTUC treatment |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year IVR free survival | no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 2 years IVR free survival | no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year | 2 years |
| Disease free survival | 2 years |
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Inclusion Criteria:
No recurrence within the last two years Are not on active bladder irrigation protocol
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuval Freifeld, Dr | Contact | +972-4-8250843 | yuvalfr@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Ashdod Hospital | Recruiting | Ashdod | Israel |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D000093542 | Gemcitabine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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Multicenter, double arm, single blinded randomized trial
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| Drug |
UTUC treatment |
|
| High grade (>3) adverse events | Adverse events that are severe or medically significant but not immediately life threatening | 2 years |
| Soroka University Medical Center | Recruiting | Beersheba | Israel |
|
| Shamir Medical Center | Recruiting | Be’er Ya‘aqov | Israel |
|
| Bnai Zion Medical Center | Recruiting | Haifa | 31048 | Israel |
|
| Carmel Medical Center | Recruiting | Haifa | 34362 | Israel |
|
| Rambam Health Care Campus | Recruiting | Haifa | Israel |
|
| Rabin Medical Center - Beilinson and Hasharon | Recruiting | Petah Tikva | 4937211 | Israel |
|
| Kaplan Medical Center | Recruiting | Rehovot | Israel |
|
| Ziv Medical Center | Recruiting | Safed | Israel |
|
| Tel Aviv Sourasky Medical Center - Ichilov | Recruiting | Tel Aviv | Israel |
|
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |