Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

Urinary Bladder Tumor Clinical Trial

Official title:

Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01581723
• Other study ID #: CUHK_TURB_2012
• Status: Recruiting
• Phase: Phase 3
• First received: March 21, 2012
• Last updated: February 2, 2015
• Start date: May 2012
• Est. completion date: September 2015

Study information

• Verified date: February 2015
• Source: Chinese University of Hong Kong
• Contact: Eddie SY Chan, MD
• Phone: +852 2632 2625
• Email: eddie[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms
• Urinary Bladder Tumor

Intervention

Device:
• Monopolar diathermy
monopolar diathermy
• Bipolar diathermy
bipolar diathermy

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin
Hong Kong	North District Hospital	Sheung Shui

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle sampling rate	To assess the charring effect to the integrity of the tumor base biopsy	An expected average of 7 days post operation	No
Primary	Incidence of TUR syndrome		Intra-operation and up to 7 days post operation	Yes
Secondary	Recurrence rate of bladder cancer		3 months and 6 months after surgery	No