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BRIEF TITLE: PK Button Vaporization Electrode for Treatment of Bladder Tumors

PK Button Vaporization Electrode for Treatment of Bladder Tumors


  • Org Study ID: IRB00053735
  • Secondary ID: PK Button and Bladder Tumors
  • NCT ID: NCT01567462
  • NCT Alias:
  • Sponsor: Emory University - Other
  • Source: Emory University

Brief Summary

The purpose of this study is to compare the uses 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 will be 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 will be to prove equivalence
in outcomes between the two techniques.

Overal Status Start Date Phase Study Type
Recruiting Start Date: December 2012 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Procedural complications

Primary Outcome 1 - Time Frame: within 30 days of procedure

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Patients with cystoscopically detected bladder tumors requiring TURBT

- Patients with bladder tumors which are endoscopically resectable by surgeon's judgment
with only one trip into the operating room.
<br/> Exclusion Criteria:

- Patients with clinical evidence of locally advanced, nodal, or metastatic bladder
cancer

- Patients with hydronephrosis secondary to bladder cancer

- Patients with diffuse tumor throughout bladder that is deemed unresectable by surgeon
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Gender: All

Minimum Age: 18 Years

Maximum Age: 89 Years

Healthy Volunteers: No

Official Information

Name: Kenneth Ogan, MD

Role: Principal Investigator

Affiliation: Emory University

Overall Contact

Name: Mersiha Torlak, MPH

Phone: 404-778-4823

Email: mhotic@emory.edu

Location

Facility Status Contact
Emory University Department of Urology
Atlanta, Georgia 30322
United States
Recruiting Mersiha Torlak, MPH
404-778-4823
mhotic@emory.edu