Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Ključne riječi
Sažetak
Opis
Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, non-randomized pilot study looking to determine whether post-Transurethral Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.
Datumi
| Posljednja provjera: | 12/31/2019 |
| Prvo podneseno: | 02/07/2019 |
| Predviđena prijava poslana: | 02/12/2019 |
| Prvo objavljeno: | 02/14/2019 |
| Posljednje ažuriranje poslano: | 01/21/2020 |
| Posljednje ažuriranje objavljeno: | 01/26/2020 |
| Stvarni datum početka studija: | 08/31/2019 |
| Procijenjeni datum primarnog završetka: | 12/29/2020 |
| Procijenjeni datum završetka studije: | 12/29/2021 |
Stanje ili bolest
Intervencija / liječenje
Procedure: Continuous Bladder Irrigation (CBI)
Faza
Grupe ruku
| Ruka | Intervencija / liječenje |
|---|---|
| Experimental: Continuous Bladder Irrigation (CBI) Each subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure.
Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples. | Procedure: Continuous Bladder Irrigation (CBI) CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure. |
Kriterij prihvatljivosti
| Dobni uvjeti za studiranje | 18 Years Do 18 Years |
| Spolovi koji ispunjavaju uvjete za studij | All |
| Prihvaća zdrave volontere | Da |
| Kriteriji | Inclusion Criteria: - Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study - Primary bladder tumor occurrence Exclusion Criteria: - Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease - Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI - Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team - Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy - History of previous pelvic radiation - Bladder tumor volume > 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging |
Ishod
Primarne mjere ishoda
1. Change in mean cells count before versus after liter 1 of CBI [Immediately after CBI procedure.]
2. Change in mean cells count before versus after liter 2 of CBI [Immediately after CBI procedure.]
3. Change in mean cells count before versus after liter 3 of CBI [Immediately after CBI procedure.]
4. Change in mean cells count before versus after liter 4 of CBI [Immediately after CBI procedure.]
5. Change in mean cells count before versus after liter 5 of CBI [Immediately after CBI procedure.]
Sekundarne mjere ishoda
1. Recurrence rate of patients who underwent CBI post TURBT. [2 years after end of treatment]
2. Progression rate of patients who underwent CBI post TURBT. [2 years after end of treatment]
