Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Bladder Tumor
• Intervention / Treatment: Device: Monopolar diathermy; Device: Bipolar diathermy

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Eddie SY Chan, MD; Phone Number: +852 2632 2625; Email: eddie@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Cleo NY Lam, BSc; Phone Number: +852 2632 1663; Email: nylam@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Principal Investigator: Eddie SY Chan, MD
    • Sub-Investigator: Chi Fai Ng, MD
    • Sub-Investigator: Simon SM Hou, MBBS
  • Sheung Shui, Hong Kong
    • Not yet recruiting
    • North District Hospital
    • Sub-Investigator: Ho Yuen Cheung, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Recurrence rate of bladder cancer	3 months and 6 months after surgery

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Eddie SY Chan, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: urinary bladder tumor; monopolar TURBT; bipolar TURBT
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CUHK_TURB_2012