We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01581723
Recruitment Status : Unknown
Verified February 2015 by Eddie SY Chan, MD, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : April 20, 2012
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Eddie SY Chan, MD, Chinese University of Hong Kong

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Bladder cancer is a common urological malignant disease. Patients with bladder cancer will first be managed with transurethral resection (TUR) of bladder tumor. For many years, monopolar transurethral resection of bladder tumor (TURP) has been the gold standard for treatment. However, complications including bleeding, bladder perforation and inadequate sampling of deep tumor biopsy remain the major concerns. Recently published papers suggested that the newer bipolar TUR technology has similar surgical outcomes but less complications comparing with monopolar TUR. In this study, investigators will investigate the benefit of new technology as compared with conventional monopolar resection on tumor clearance, complication and recurrence rates.

Condition or disease Intervention/treatment Phase
Urinary Bladder Tumor Device: Monopolar diathermy Device: Bipolar diathermy Phase 3

Detailed Description:

Transurethral resection (TUR) of bladder tumor is one of commonest procedures in urology practice. It is the surgery of choice for staging and treating non-muscle invasive bladder cancer. Short lengths of hospital stay, simple and safe are the main advantages of the surgery. Conventional TUR is performed with monopolar diathermy, which commonly elicits obturator reflexes in lateral-located tumor. However, it is not without complication. Bleeding and bladder perforation with or without obturator reflex are the most significant complications after TUR of bladder tumor. The charring effect of monopolar is also a concern as the diagnosis of muscle invasion by tumor is determined by the integrity of tumor base biopsy. Mariappan et al. reported that as high as 33% of the specimen had no detrusor muscle present for assessment. The absent of muscle not only affect the staging procedure but also associated with higher cancer recurrence rate.

Bipolar resection has been widely used in transurethral resection of prostate (TURP). As compared with the traditional monopolar technology, the electric current passes through the instrument sheath. The advantage of bipolar technology includes less obturator reflex, good hemostasis and early recovery. Study has showed that the cautery artifact is more severe on monopolar resection as compared with bipolar in prostate tissues. Due to the clean and precise cutting, there will be less charring on the specimen and thermal injury to peripheral tissues. Applying to bladder tumor resection, this will improve the staging accuracy with better determination of the depth of invasion. Furthermore, with the use of saline instead of glycine as irrigation fluid, risk of TUR syndrome is minimized. There is no randomized trial on the benefit of using bipolar instrument on TUR bladder cancer. In this study, investigator will investigate the role of bipolar technology in TUR bladder cancer as compared with traditional monopolar resection.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial
Study Start Date : May 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Monopolar TUR
Monopolar diathermy is used to perform tranurethral resection of bladder tumor
 Device: Monopolar diathermy
monopolar diathermy
Other Names:
  • Olympus Monopolar HF-resection Electrode
  • Model: A22205A
Experimental: Biploar TUR
Bipolar diathermy is used to perform transurethral resection of bladder tumor
 Device: Bipolar diathermy
bipolar diathermy
Other Names:
  • Olympus TURis Bipolar HF-resection electrode
  • Model: WA22306D


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Muscle sampling rate [ Time Frame: An expected average of 7 days post operation ]
    To assess the charring effect to the integrity of the tumor base biopsy

  2. Incidence of TUR syndrome [ Time Frame: Intra-operation and up to 7 days post operation ]

Secondary Outcome Measures :
  1. Recurrence rate of bladder cancer [ Time Frame: 3 months and 6 months after surgery ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female patients (age ≥ 18)
  • Patients who have diagnosed with bladder cancer (either primary or recurrent) by cystoscopy

Exclusion Criteria:

  • Patients who are scheduled for second TUR within 6 weeks after the previous TUR
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01581723


Contacts
Layout table for location contacts
Contact: Eddie SY Chan, MD +852 2632 2625 eddie@surgery.cuhk.edu.hk
Contact: Cleo NY Lam, BSc +852 2632 1663 nylam@surgery.cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Principal Investigator: Eddie SY Chan, MD         
Sub-Investigator: Chi Fai Ng, MD         
Sub-Investigator: Simon SM Hou, MBBS         
North District Hospital Not yet recruiting
Sheung Shui, Hong Kong
Sub-Investigator: Ho Yuen Cheung, MBChB         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Eddie SY Chan, MD Chinese University of Hong Kong
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Eddie SY Chan, MD, Dr., Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01581723    
Other Study ID Numbers: CUHK_TURB_2012
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Eddie SY Chan, MD, Chinese University of Hong Kong:
urinary bladder tumor
monopolar TURBT
bipolar TURBT
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases