Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

TCC Clinical Trial

Official title:

Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04147182
• Other study ID #: 0116-17-KMC
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 2, 2018
• Est. completion date: November 3, 2020

Study information

• Verified date: October 2019
• Source: Kaplan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: November 3, 2020
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• TCC

Intervention

Drug:
• Hypertonic Saline 3%
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.

Locations

Country	Name	City	State
Israel	Kaplan MC	Re?ovot

Sponsors (1)

Lead Sponsor	Collaborator
Dan Leibovici

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	12 month