TCC
Conditions
Brief summary
Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.
Interventions
3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents.
Sponsors
Dan Leibovici
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of 18 years or older able to sign informed consent 2. A previous diagnosis of low grade bladder cancer 3. A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion 4. Serum creatinine levels ≤ 2.0 mg/dl 5. Serum sodium levels \<146 mg/ml 6. Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months 7. Patient is candidate for TURBT
Exclusion criteria
1. Previous history of high grade bladder cancer including carcinoma in situ 2. Presence of upper urinary tract tumor on imaging 3. Renal failure with serum creatinine \>2.0 mg/dl prior to inclusion 4. Hypernatremia \>146 mg/dl prior to inclusion 5. Contra-indication to undergo TURBT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo. | 12 month | The investigators monitored the Sodium levels in the blood after the administration of the Hypertonic Saline and documented and measure side effects by Clavien-Dindo scale |
Countries
Israel
Outcome results
None listed