Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
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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 |
- 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 ]
- 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: | July 2014 |
| Estimated Primary Completion Date: | March 2014 (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:
|
|
Experimental: Biploar TUR
Bipolar diathermy is used to perform transurethral resection of bladder tumor
|
Device: Bipolar diathermy
bipolar diathermy
Other Names:
|
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 |
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| 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 |
| 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 | |
| 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: | May 13, 2012 |
| 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 Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013