PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors (PK Button)
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|ClinicalTrials.gov Identifier: NCT01567462|
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: Monopolar electrocautery loop in Transurethral resection of bladder tumors Device: PK Button Vaporization Electrode in transurethral resection of bladder tumors||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PK Button Vaporization Electrode for Treatment of Bladder Tumors|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 28, 2017|
|Actual Study Completion Date :||March 28, 2017|
Active Comparator: Monopolar Electrocautery
The current treatment standard of care for patients who present de novo or with a recurrent bladder tumor is transurethral resection of the bladder tumor (TURBT) using monopolar electrocautery in the form a 90-degree loop electrode and has been used since its introduction in 1952. This intervention, accomplished endoscopically through the urethra, is both diagnostic and potentially therapeutic. An adequately performed TURBT will provide the pathologist with enough tissue to provide tumor grade and stage information.
Device: Monopolar electrocautery loop in Transurethral resection of bladder tumors
Standard monopolar electrocautery loop in transurethral resection of bladder tumors (TURBT)
Active Comparator: PK Button Vaporization Electrode
Bipolar energy has been available for many years and has been readily adopted for the surgical treatment of benign prostatic enlargement and may provide advantages and solutions to the technical challenges of monopolar electrocautery. A further refinement on bipolar energy has been the recent introduction of the PlasmaKinetic (PK) Button Vaporization electrode which will be used in the intervention arm of this study. This electrode is already approved by the Food and Drug Administration (FDA) for this indication as well. The semi-spherical design of the electrode creates a plasma arc that glides over the tissue, transmitting energy to the cell layers adjacent to the arc which are then quickly vaporized.
Device: PK Button Vaporization Electrode in transurethral resection of bladder tumors
PlasmaKinetic (PK) Button Vaporization Electrode in transurethral resection of bladder tumors (TURBT)
- Number of Procedural Complications [ Time Frame: Post-Intervention (Up to 30 Days) ]The number of procedural complications describes the total number of post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation events that occur within thirty days of the procedure.
- Mean Operative Time [ Time Frame: After Surgery Completion, Up to 174 Minutes ]The average operative time was measured through study completion.
- Mean Catheterization Time [ Time Frame: After Surgery Completion, Up to 336 Hours ]The average duration of the catheterization time was measured through study completion.
- Number of Participants With Disease Recurrence [ Time Frame: Post-Intervention (Up to 4 Months) ]The number of participants who had disease recurrence within the four month follow up period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567462
|United States, Georgia|
|Emory University Department of Urology|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kenneth Ogan, MD||Emory University|