Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

NCT ID: NCT04147182

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-02
• Study Completion Date: 2020-11-03

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.

Conditions

TCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient with low grade TCC

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

Group Type: EXPERIMENTAL

Hypertonic Saline 3%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dan Leibovici

OTHER

Sponsor Role: lead

Responsible Party

Dan Leibovici

Professor Dan Leibovici- Head of the Urology department of Kaplan MC

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kaplan MC

Rehovot, , Israel

Countries

Israel

Other Identifiers

0116-17-KMC

Identifier Type: -

Identifier Source: org_study_id