Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

NCT04147182 | Unknown Phase 1

• 1 other identifier: 0116-17-KMC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient with low grade TCC

EXPERIMENTAL

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

Drug: Hypertonic Saline 3%

Interventions

Hypertonic Saline 3% 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.

Patient with low grade TCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 18 years or older able to sign informed consent
• A previous diagnosis of low grade bladder cancer
• 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

You may not qualify if:

• Previous history of high grade bladder cancer including carcinoma in situ
• Presence of upper urinary tract tumor on imaging
• Contra-indication to undergo TURBT

Sponsors & Collaborators

• Dan Leibovici: lead

Study Sites (1)

Kaplan MC

Rehovot, Israel

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dan Leibovici- Head of the Urology department of Kaplan MC

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 31, 2019
• Study Start: December 2, 2018
• Primary Completion: July 3, 2019
• Study Completion: November 3, 2020
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)