Status:
UNKNOWN
The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer
Lead Sponsor:
Kaplan Medical Center
Conditions:
TCC
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT. Design: prospective randomized double-blind placebo contro...
Detailed Description
Non-muscle invasive bladder cancer is associated with a high recurrence rate. As a result, clinical guidelines mandate prophylactic treatment in all patients who experience tumor recurrence after the ...
Eligibility Criteria
Inclusion
- 1\. Age ≥18 years, men and women who are scheduled for TURBT at our center 2. Newly diagnosed papillary bladder tumors \< 3cm in largest diameter at cystoscopy 3. Normal upper tracts as determined by CTU/MRU either during the 1 year before TURBT of done within one month after TURBT 4. Serum creatinine level ≤ 2.5 mg / dl before inclusion 5. Serum sodium level \<145 meq/ dl before inclusion
Exclusion
- 1\. Previous diagnosis of urothelial carcinoma 2. Solid tumors or larger than 3 cm in diameter 3. Any patient with concurrent upper tract TCC by either imaging or endoscopy 4. Patients with preoperative hypernatremia \>145 meq/dl 5. Patients with preoperative renal failure serum creatinine level \>2.5 mg / dl 6. Patients with indwelling double J stents or when such a stent is inserted during the TURBT
- Abortion Criteria:
- Resections that mandate CBI (continuous bladder irrigation)
- Incomplete resections / endoscopic appearance of MIBC
- Suspected bladder perforation
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04671407
Start Date
January 20 2021
End Date
December 1 2022
Last Update
February 18 2021
Active Locations (1)
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1
Kaplan MC
Rehovot, Israel