PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to compare the use of two types of equipment during
      transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the
      monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These
      two devices do the same task but differ in the way they create electric current when removing
      cancerous tissue. The investigators hope to examine and compare the uses of these two
      surgical devices to see if any advantages do exist or whether they actually are similar. The
      goal of the study is to prove similarity in outcomes between the two techniques and analyze
      the outcomes resulting from each case.
    

Detailed description: 
      This study will study the medical intervention used when bladder cancer patients present with
      a new or recurrent bladder tumor. Currently when patients report these tumors, they undergo a
      standard practice called transurethral resection of the bladder tumor (TURBT) in order to
      determine the stage of the cancer. This intervention, accomplished by looking through the
      urethra using an endoscope, is both diagnostic and potentially therapeutic. An adequately
      performed TURBT will provide the pathologist with enough tissue to provide tumor grade and
      stage information. Currently, TURBT is done using equipment called monopolar electrocautery
      which is in the form a 90-degree loop electrode. Although usually safe and sufficient, this
      technique can create technical challenges because it can be difficult to position the loop
      electrode in a dynamically changing cylindrical space (the bladder). Specifically, especially
      with larger bladder tumors, intraoperative bleeding can obscure visualization and result in
      incomplete tumor resection as well as inadequate sampling of the layers of the bladder needed
      to establish tumor stage. Furthermore, monopolar current can result in stimulation of a nerve
      (the obturator nerve) during resection of wall tumors, resulting in violent movement of the
      leg which can cause a potential bladder tear as well as possible (iliac) vessel injury.

      Conversely, a technique using bipolar energy, which has been available for many years, has
      been readily adopted for the surgical treatment of benign prostatic enlargement. The
      advantages of a bipolar electrical current include the direct return of electrical current to
      the loop rather than to a grounding pad placed on the patient's skin. This has the
      theoretical value of limiting the diffusion of electrical current, and therefore heat, to the
      surrounding tissue. A further refinement on bipolar energy has been the recent introduction
      of a piece of equipment called the PlasmaKinetic (PK) Button Vaporization electrode, which is
      currently approved by the Food and Drug Administration (FDA) for this indication. Coupling
      bipolar energy into the Button electrode would not only harness the benefits of less thermal
      spread but also would obviate the geometric challenges associated with loop electrodes during
      resection of bladder tumors. Procedural advantages would potentially include minimal
      bleeding, good visualization, and a reduction in the occurrence of the obturator reflex and
      concomitant bladder perforation.

      This study is a randomized double-arm trial examining the results of both techniques for
      bladder cancer TURBT procedures with a minimum of 120 patients at Emory. The purpose of this
      study is to measure the procedural (intraoperative), short term, as clinically indicated (4-6
      weeks), and long-term (3 months) outcomes of TURBT using the PK Button when compared to
      traditional monopolar loop electrocautery. The goal of the study is to prove equivalence in
      outcomes between the two techniques.
    

Intervention name(s): Monopolar electrocautery loop in Transurethral resection of bladder tumors; PK Button Vaporization Electrode in transurethral resection of bladder tumors
Intervention type(s): Device; Device
Intervention description(s): Standard monopolar electrocautery loop in transurethral resection of bladder tumors (TURBT); PlasmaKinetic (PK) Button Vaporization Electrode in transurethral resection of bladder tumors (TURBT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bladder cancer; transurethral resection of bladder tumors