Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

NCT ID: NCT01581723

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Urinary Bladder Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Monopolar TUR

Monopolar diathermy is used to perform tranurethral resection of bladder tumor

Group Type: ACTIVE_COMPARATOR

Monopolar diathermy

Intervention Type: DEVICE

monopolar diathermy

Biploar TUR

Bipolar diathermy is used to perform transurethral resection of bladder tumor

Group Type: EXPERIMENTAL

Bipolar diathermy

Intervention Type: DEVICE

bipolar diathermy

Interventions

Monopolar diathermy

monopolar diathermy

Intervention Type: DEVICE

Bipolar diathermy

bipolar diathermy

Intervention Type: DEVICE

Other Intervention Names

Olympus Monopolar HF-resection Electrode; Model: A22205A; Olympus TURis Bipolar HF-resection electrode; Model: WA22306D

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Eddie SY Chan, MD

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eddie SY Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status: RECRUITING

North District Hospital

Sheung Shui, , Hong Kong

Site Status: NOT_YET_RECRUITING

Countries

Hong Kong

Central Contacts

Eddie SY Chan, MD

Role: CONTACT

eddie@surgery.cuhk.edu.hk

+852 2632 2625

Cleo NY Lam, BSc

Role: CONTACT

nylam@surgery.cuhk.edu.hk

+852 2632 1663

Other Identifiers

CUHK_TURB_2012

Identifier Type: -

Identifier Source: org_study_id