Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

Phase 1

• Conditions: TCC
• Interventions: Drug: Hypertonic Saline 3%

• Registration Number: NCT04147182
• Lead Sponsor: Dan Leibovici

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-02
• Primary Completion: 2019-07-03
• Status Verified: 2019-10
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-04
• Study Completion: 2020-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with low grade TCC	Hypertonic Saline 3%	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kaplan MC; 🇮🇱 Reẖovot, Israel