Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

• ClinicalTrials.gov Identifier: NCT01581723
• Recruitment Status: Unknown
• First Posted: April 20, 2012
• Last Update Posted: February 4, 2015
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Eddie SY Chan, MD, Chinese University of Hong Kong

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Urinary Bladder Tumor	Device: Monopolar diathermy; Device: Bipolar diathermy	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial
• Study Start Date: May 2012
• Estimated Primary Completion Date: June 2015
• Estimated Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Muscle sampling rate [ Time Frame: An expected average of 7 days post operation ]
   To assess the charring effect to the integrity of the tumor base biopsy
2. Incidence of TUR syndrome [ Time Frame: Intra-operation and up to 7 days post operation ]

Secondary Outcome Measures :

1. Recurrence rate of bladder cancer [ Time Frame: 3 months and 6 months after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Eddie SY Chan, MD, Dr., Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01581723
• Other Study ID Numbers: CUHK_TURB_2012
• First Posted: April 20, 2012
• Last Update Posted: February 4, 2015
• Last Verified: February 2015

Keywords provided by Eddie SY Chan, MD, Chinese University of Hong Kong:

urinary bladder tumor; monopolar TURBT; bipolar TURBT

Additional relevant MeSH terms:

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