Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

Sponsor

Dan Leibovici (Other)

Overall Status

Unknown status

CT.gov ID

NCT04147182

Collaborator

(none)

Enrollment

Location

Arm

23.1

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TCC	Drug: Hypertonic Saline 3%	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder

Actual Study Start Date :

Dec 2, 2018

Actual Primary Completion Date :

Jul 3, 2019

Anticipated Study Completion Date :

Nov 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient with low grade TCC Patients of 18 years or older able to sign informed consent A previous diagnosis of low grade bladder cancer A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion Serum creatinine levels ≤ 2.0 mg/dl Serum sodium levels <146 mg/ml Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months Patient is candidate for TURBT	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.

Arm

Intervention/Treatment

Experimental: Patient with low grade TCC

Patients of 18 years or older able to sign informed consent A previous diagnosis of low grade bladder cancer A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion Serum creatinine levels ≤ 2.0 mg/dl Serum sodium levels <146 mg/ml Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months Patient is candidate for TURBT

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of 18 years or older able to sign informed consent
A previous diagnosis of low grade bladder cancer
A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
Serum creatinine levels ≤ 2.0 mg/dl
Serum sodium levels <146 mg/ml
Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
Patient is candidate for TURBT

Exclusion Criteria:

Previous history of high grade bladder cancer including carcinoma in situ
Presence of upper urinary tract tumor on imaging
Renal failure with serum creatinine >2.0 mg/dl prior to inclusion
Hypernatremia >146 mg/dl prior to inclusion
Contra-indication to undergo TURBT

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaplan MC	Reẖovot		Israel

Sponsors and Collaborators

Dan Leibovici

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dan Leibovici, Professor Dan Leibovici- Head of the Urology department of Kaplan MC, Kaplan Medical Center

ClinicalTrials.gov Identifier:

NCT04147182

Other Study ID Numbers:

0116-17-KMC

First Posted:

Oct 31, 2019

Last Update Posted:

Nov 4, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Nov 4, 2019