Description:
The purpose of this pilot study is to determine if washing out the bladder with large volumes
of saline after surgical removal of bladder tumors helps to decrease the number of loose
cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence
and/or progression rates will be measured.
Title
- Brief Title: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
- Official Title: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Clinical Trial IDs
- ORG STUDY ID:
CASE12818
- NCT ID:
NCT03839472
Conditions
- Non-muscle Invasive Bladder Cancer (NMIBC)
- Bladder Tumor (TURBT)
Purpose
The purpose of this pilot study is to determine if washing out the bladder with large volumes
of saline after surgical removal of bladder tumors helps to decrease the number of loose
cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence
and/or progression rates will be measured.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Continuous Bladder Irrigation (CBI) | Experimental | 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. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Change in mean cells count before versus after liter 1 of CBI |
Time Frame: | Immediately after CBI procedure. |
Safety Issue: | |
Description: | The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI. |
Secondary Outcome Measures
Measure: | Recurrence rate of patients who underwent CBI post TURBT. |
Time Frame: | 2 years after end of treatment |
Safety Issue: | |
Description: | Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.
Recurrence is defined as the identification of a recurrent tumor of same grade and or stage or lower |
Measure: | Progression rate of patients who underwent CBI post TURBT. |
Time Frame: | 2 years after end of treatment |
Safety Issue: | |
Description: | Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates.
Progression is defined as a recurrent tumor of higher grade and or stage |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Suspended |
Lead Sponsor: | Case Comprehensive Cancer Center |
Last Updated
May 7, 2021