This randomized clinical trial studies transurethral resection of bladder tumors using PlasmaKinetic (PK) button vaporization electrode or monopolar loop electrocautery in treating patients with bladder cancer. Transurethral resection of bladder tumors using PK button vaporization is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. It is not yet known whether PK button vaporization electrode or monopolar loop electrocautery works better in treating bladder cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT01567462.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To measure the procedural (intraoperative), short term, as clinically indicated, (4-6 weeks), and long-term (3 months) outcomes of transurethral resection of the bladder tumor (TURBT) using the PK button when compared to traditional monopolar loop electrocautery.
SECONDARY OBJECTIVES:
I. Assessment of operative time, tumor recurrence, catheterization time, and amount of thermal spread or cautery artifact in biopsies of tumor base.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo PK Button vaporization electrode TURBT.
ARM II: Patients undergo traditional monopolar loop electrocautery TURBT.
After completion of study treatment, patients are followed up at 4-6 weeks and 4 months or closest standard of care visits.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorKenneth Ogan
