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Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

Primary Purpose

Urinary Bladder Tumor

Status
Unknown status
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Monopolar diathermy
Bipolar diathermy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Tumor focused on measuring urinary bladder tumor, monopolar TURBT, bipolar TURBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales HospitalRecruiting
  • North District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monopolar TUR

Biploar TUR

Arm Description

Monopolar diathermy is used to perform tranurethral resection of bladder tumor

Bipolar diathermy is used to perform transurethral resection of bladder tumor

Outcomes

Primary Outcome Measures

Muscle sampling rate
To assess the charring effect to the integrity of the tumor base biopsy
Incidence of TUR syndrome

Secondary Outcome Measures

Recurrence rate of bladder cancer

Full Information

First Posted
March 21, 2012
Last Updated
February 2, 2015
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01581723
Brief Title
Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
Official Title
Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Tumor
Keywords
urinary bladder tumor, monopolar TURBT, bipolar TURBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monopolar TUR
Arm Type
Active Comparator
Arm Description
Monopolar diathermy is used to perform tranurethral resection of bladder tumor
Arm Title
Biploar TUR
Arm Type
Experimental
Arm Description
Bipolar diathermy is used to perform transurethral resection of bladder tumor
Intervention Type
Device
Intervention Name(s)
Monopolar diathermy
Other Intervention Name(s)
Olympus Monopolar HF-resection Electrode, Model: A22205A
Intervention Description
monopolar diathermy
Intervention Type
Device
Intervention Name(s)
Bipolar diathermy
Other Intervention Name(s)
Olympus TURis Bipolar HF-resection electrode, Model: WA22306D
Intervention Description
bipolar diathermy
Primary Outcome Measure Information:
Title
Muscle sampling rate
Description
To assess the charring effect to the integrity of the tumor base biopsy
Time Frame
An expected average of 7 days post operation
Title
Incidence of TUR syndrome
Time Frame
Intra-operation and up to 7 days post operation
Secondary Outcome Measure Information:
Title
Recurrence rate of bladder cancer
Time Frame
3 months and 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eddie SY Chan, MD
Phone
+852 2632 2625
Email
eddie@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Cleo NY Lam, BSc
Phone
+852 2632 1663
Email
nylam@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddie SY Chan, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddie SY Chan, MD
First Name & Middle Initial & Last Name & Degree
Chi Fai Ng, MD
First Name & Middle Initial & Last Name & Degree
Simon SM Hou, MBBS
Facility Name
North District Hospital
City
Sheung Shui
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Yuen Cheung, MBChB

12. IPD Sharing Statement

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Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

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