Urinary Bladder TumorPhase 3NCT01581723
Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
A Phase 3 study testing Monopolar diathermy and Bipolar diathermy in people with Urinary Bladder Tumor, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Tumor
- What is being tested?
- Monopolar diathermy and Bipolar diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesHong Kong
- Study dates
- May 2012to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients (age ≥ 18)
- Patients who have diagnosed with bladder cancer (either primary or recurrent) by cystoscopy
Who cannot join
- Patients who are scheduled for second TUR within 6 weeks after the previous TUR
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Eddie SY Chan, MD
Chi Fai Ng, MD
- Not yet recruiting
North District Hospital
Sheung Shui
Ho Yuen Cheung, MBChB
About this study
Official title: 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.
Read the 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
- Being tested
- Monopolar diathermy, Bipolar diathermy
- Keywords
- urinary bladder tumor, monopolar TURBT, bipolar TURBT
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar diathermyDevice
Also called Olympus Monopolar HF-resection Electrode, Model: A22205A
monopolar diathermy
Bipolar diathermyDevice
Also called Olympus TURis Bipolar HF-resection electrode, Model: WA22306D
bipolar diathermy
| Study group | Role | What they receive |
|---|---|---|
| Monopolar TUR | Active comparator | Monopolar diathermy is used to perform tranurethral resection of bladder tumor Receives: Device: Monopolar diathermy |
| Biploar TUR | Experimental | Bipolar diathermy is used to perform transurethral resection of bladder tumor Receives: Device: Bipolar diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sampling rate
To assess the charring effect to the integrity of the tumor base biopsy
Measured: An expected average of 7 days post operation
Incidence of TUR syndrome
Measured: Intra-operation and up to 7 days post operation
Secondary outcomes (1)
Recurrence rate of bladder cancer
Measured: 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder TumorStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eddie SY Chan, MD, Chinese University of Hong Kong
- Investigators
- Eddie SY Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581723
- Sponsor's protocol ID
- CUHK_TURB_2012
- Status last verified
- Feb 2015
- First submitted
- 21 Mar 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01581723
- Acronym / sponsor ID
- CUHK_TURB_2012
- Conditions
- Urinary Bladder Tumor
- Keywords
- urinary bladder tumor, monopolar TURBT, bipolar TURBT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monopolar TUR | Active comparator | Device: Monopolar diathermyMonopolar diathermy is used to perform tranurethral resection of bladder tumor |
| Biploar TUR | Experimental | Device: Bipolar diathermyBipolar diathermy is used to perform transurethral resection of bladder tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male or female patients (age ≥ 18)
- Patients who have diagnosed with bladder cancer (either primary or recurrent) by cystoscopy
Key exclusion criteria (1 listed)
- Patients who are scheduled for second TUR within 6 weeks after the previous TUR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monopolar diathermyAlso: Olympus Monopolar HF-resection Electrode, Model: A22205Amonopolar diathermy | Device | Monopolar TUR |
| Bipolar diathermyAlso: Olympus TURis Bipolar HF-resection electrode, Model: WA22306Dbipolar diathermy | Device | Biploar TUR |
Primary outcome
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
Incidence of TUR syndrome
Time frame: Intra-operation and up to 7 days post operation
1 secondary outcome
Recurrence rate of bladder cancer
Time frame: 3 months and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddie SY Chan, MD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Monopolar diathermy and Bipolar diathermy in people with Urinary Bladder Tumor, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eddie SY Chan, MD (+852 2632 2625, eddie@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle sampling rate (time frame: An expected average of 7 days post operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.