Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Chinese University of Hong Kong

Sponsor:

Information provided by (Responsible Party):

Eddie SY Chan, MD, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT01581723

First received: March 21, 2012

Last updated: February 2, 2015

Last verified: February 2015

History of Changes

Purpose

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	Intervention	Phase
Urinary Bladder Tumor	Device: Monopolar diathermy Device: Bipolar diathermy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Muscle sampling rate [ Time Frame: An expected average of 7 days post operation ] [ Designated as safety issue: No ]
To assess the charring effect to the integrity of the tumor base biopsy
Incidence of TUR syndrome [ Time Frame: Intra-operation and up to 7 days post operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Recurrence rate of bladder cancer [ Time Frame: 3 months and 6 months after surgery ] [ Designated as safety issue: No ]


Estimated Enrollment:	150
Study Start Date:	May 2012
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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: NCT01581723

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


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


Principal Investigator:	Eddie SY Chan, MD	Chinese University of Hong Kong

More Information

No publications provided


Responsible Party:	Eddie SY Chan, MD, Dr., Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01581723 History of Changes
Other Study ID Numbers:	CUHK_TURB_2012
Study First Received:	March 21, 2012
Last Updated:	February 2, 2015
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:


urinary bladder tumor monopolar TURBT bipolar TURBT

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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