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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01567462
First received: March 27, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Device: Monopolar electrocautery loop in Transurethral resection of bladder tumors
Device: PK Button Vaporization Electrode in transurethral resection of bladder tumors

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PK Button Vaporization Electrode for Treatment of Bladder Tumors

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567462

Contacts
Contact: Kenneth Ogan, MD 404-778-4898 kogan@emory.edu
Contact: Lane Ringer, BS 404-778-4162 eringer@emory.edu

Locations
United States, Georgia
Emory University Department of Urology Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lane Ringer, BS    404-778-4162    eringer@emory.edu   
Sponsors and Collaborators
Emory University
Olympus
Investigators
Principal Investigator: Daniel Canter, MD Emory University
  More Information

No publications provided

Responsible Party: Kenneth Ogan, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01567462     History of Changes
Other Study ID Numbers: IRB00053735, PK Button and Bladder Tumors
Study First Received: March 27, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014