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

• ClinicalTrials.gov Identifier: NCT01567462
• Recruitment Status: Completed
• First Posted: March 30, 2012
• Results First Posted: December 8, 2017
• Last Update Posted: December 8, 2017
• Sponsor: Emory University
• Collaborator: Olympus
• Information provided by (Responsible Party): Kenneth Ogan, MD, Emory University

Study Description

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Mean Operative Time [ Time Frame: After Surgery Completion, Up to 174 Minutes ]
   The average operative time was measured through study completion.
2. Mean Catheterization Time [ Time Frame: After Surgery Completion, Up to 336 Hours ]
   The average duration of the catheterization time was measured through study completion.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Emory University Department of Urology

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Olympus

Investigators

• Principal Investigator: Kenneth Ogan, MD; Emory University

  Study Documents (Full-Text)

Documents provided by Kenneth Ogan, MD, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] February 13, 2015

More Information

• Responsible Party: Kenneth Ogan, MD, Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT01567462
• Other Study ID Numbers: IRB00053735; PK Button and Bladder Tumors ( Other Identifier: Other )
• First Posted: March 30, 2012
• Results First Posted: December 8, 2017
• Last Update Posted: December 8, 2017
• Last Verified: October 2017

Keywords provided by Kenneth Ogan, MD, Emory University:

bladder cancer; transurethral resection of bladder tumors

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases