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Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

D

Dan Leibovici

Status and phase

Unknown
Phase 1

Conditions

TCC

Treatments

Drug: Hypertonic Saline 3%

Study type

Interventional

Funder types

Other

Identifiers

NCT04147182
0116-17-KMC

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Patient with low grade TCC
Experimental group
Description:
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
Treatment:
Drug: Hypertonic Saline 3%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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