Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

NCT01581723 | Unknown Phase 3

• 1 other identifier: CUHK_TURB_2012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Bladder Tumor

Keywords

urinary bladder tumor; monopolar TURBT; bipolar TURBT

Outcome Measures

Primary Outcomes (2)

• Muscle sampling rate

  To assess the charring effect to the integrity of the tumor base biopsy

  An expected average of 7 days post operation

• Incidence of TUR syndrome

  Intra-operation and up to 7 days post operation

Secondary Outcomes (1)

• Recurrence rate of bladder cancer

  3 months and 6 months after surgery

Study Arms (2)

Monopolar TUR

ACTIVE COMPARATOR

Monopolar diathermy is used to perform tranurethral resection of bladder tumor

Device: Monopolar diathermy

Biploar TUR

EXPERIMENTAL

Bipolar diathermy is used to perform transurethral resection of bladder tumor

Device: Bipolar diathermy

Interventions

Monopolar diathermy DEVICE

monopolar diathermy

Also known as: Olympus Monopolar HF-resection Electrode, Model: A22205A

Monopolar TUR

Bipolar diathermy DEVICE

bipolar diathermy

Also known as: Olympus TURis Bipolar HF-resection electrode, Model: WA22306D

Biploar TUR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are scheduled for second TUR within 6 weeks after the previous TUR

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

North District Hospital

Sheung Shui, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Eddie SY Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eddie SY Chan, MD

CONTACT

+852 2632 2625; eddie@surgery.cuhk.edu.hk

Cleo NY Lam, BSc

CONTACT

+852 2632 1663; nylam@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: April 20, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

HK (2)