PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors

• Procedural complications [ Time Frame: within 30 days of procedure ] [ Designated as safety issue: No ]
  The primary endpoint will be the measurements of procedural complications, which include post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation. The expected rate of composite complications is 10-15%. If one or more of the aforementioned complications occur, then the case will be recorded to have a complication.
  
  

• Operative follow-up [ Time Frame: Patients will be followed on average for 4 months following the procedure. Actual dates will coincide with when they can schedule their post-operative visits. ] [ Designated as safety issue: No ]
  One secondary endpoint will be the assessment of the length of operative time.
  
  
• Operative follow-up [ Time Frame: Patients will be followed on average for 4 months following the procedure. Actual dates will coincide with when they can schedule their post-operative visits. ] [ Designated as safety issue: No ]
  One secondary endpoint will be the assessment of whether there is tumor recurrence following the procedure.
  
  
• Operative follow-up [ Time Frame: Patients will be followed on average for 4 months following procedure. Actual dates will coincide with when they can schedule their post-operative visits. ] [ Designated as safety issue: No ]
  One secondary endpoint will be the assessment of the amount of thermal spread or cautery artifact in biopsies of tumor base.
  
  

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 will be to prove equivalence in outcomes between the two techniques.