Clinical Trials /

Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

NCT03839472

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.

Related Conditions:
  • Bladder Neoplasm
Recruiting Status:

Suspended

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03839472

Trial Eligibility

Document

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

NameTypeDescriptionInterventions
Continuous Bladder Irrigation (CBI)ExperimentalEach 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