Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder

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.

Study Overview

• Status: Unknown
• Conditions: TCC
• Intervention / Treatment: Drug: Hypertonic Saline 3%

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Reẖovot, Israel
    • Kaplan MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dan Leibovici

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2018
• Primary Completion (Actual): July 3, 2019
• Study Completion (Anticipated): November 3, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0116-17-KMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No