Clinical trial NCT01567462: PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors
Official title: PK Button Vaporization Electrode for Treatment of Bladder Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
transurethral resection of bladder tumors
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2012-03-30
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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

Primary outcomes:
measure: Number of Procedural Complications
timeFrame: Post-Intervention (Up to 30 Days)
Secondary outcomes:
measure: Mean Operative Time
timeFrame: After Surgery Completion, Up to 174 Minutes
measure: Mean Catheterization Time
timeFrame: After Surgery Completion, Up to 336 Hours
measure: Number of Participants With Disease Recurrence
timeFrame: Post-Intervention (Up to 4 Months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Department of Urology
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References: