Bladder CancerNCT04081246
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
A study testing Bipolar transurethral modified en bloc resection of bladder tumour in people with Bladder Cancer and Bladder Neoplasm, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Modified en bloc resection is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. In this study, we shall investigate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm in size. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer, Bladder Neoplasm, Bladder Tumor
- What is being tested?
- Bipolar transurethral modified en bloc resection of bladder tumour
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Sep 2020to 15 Mar 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years old with informed consent
- Bladder tumours with maximal dimension of ≥ 3cm
Who cannot join
- Bladder tumour detected during intravesical Bacillus Calmette-Guerin therapy (These patients warrant more aggressive treatment, i.e. radical cystectomy)
- Estimated glomerular filtration rate of <60mL/min.
- Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
- Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
- History of bleeding disorder or use of anti-coagulant
- Presence of other active malignancy
Show all 10Show fewer
- ECOG performance status ≥ 2 (Ambulatory and capable of all self care but unable to carry our any work activities. Confined to bed or chair less than 50% of waking hours)
- Pregnancy
- Presence of metallic foreign body or implant which is not MRI compatible
- Known history of claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Modified en bloc resection is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. In this study, we shall investigate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm in size.
Read the detailed description
The biggest limiting factor of en bloc resection is the size of the bladder tumour. Resection of the bladder tumour is technically feasible, but the retrieval of specimen in one piece is restricted by the narrow size of the urethra. However, the greatest advantage of en bloc resection is to ensure complete local resection rather than the theoretical benefit of avoiding tumour re-implantation. Therefore, the concept of modified en bloc resection for large bladder tumours of ≥3cm has evolved. It is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. By resecting the exophytic part of the bladder tumour, the size of main tumour bulk can be reduced. By performing en bloc resection of the tumour base, the advantage of ensuring complete tumour resection beneath the submucosal plane can be preserved, and the tumour base specimen remains intact for histological assessment of the resection margins. Modified en bloc resection is a promising surgical technique which can potentially ensure complete tumour resection, reduce the need of second-look transurethral resection, and improve the oncological control of non-muscle-invasive bladder cancer in long run. It may also ensure proper staging of muscle-invasive bladder cancer at the first surgery, thus avoiding the need of second-look transurethral resection in under-staged patients.
In this study, we shall evaluate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm. All patients will have MRI before modified en bloc resection. All patients with non-muscle-invasive bladder cancer will be offered second-look transurethral resection in 2-6 weeks' time. All patients with muscle-invasive bladder cancer but not distant metastasis will be offered radical cystectomy, pelvic lymphadenectomy and urinary diversion; for those who refuse or who are considered unfit for radical surgery, second-look transurethral resection will be offered. All patients will have a second MRI before the second surgery. The modified en bloc resection specimen results will be compared with the final pathology results in the second surgery. The presence of any residual or upstaging of disease will be determined. The results of the two sets of MRI will also be compared with the final pathology results. The accuracy of MRI in the evaluation of bladder cancer will be determined.
- Conditions
- Bladder Cancer, Bladder Neoplasm, Bladder Tumor
- Being tested
- Bipolar transurethral modified en bloc resection of bladder tumour
- Keywords
- Bladder cancer, bladder tumour, en bloc resection
- 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.
Bipolar transurethral modified en bloc resection of bladder tumourDevice
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
| Study group | Role | What they receive |
|---|---|---|
| Modified en bloc resection | Experimental | For patients undergoing modified en bloc resection, piecemeal resection of the exophytic part of the bladder tumour will be performed, followed by en bloc resection of the tumour base. Receives: Device: Bipolar transurethral modified en bloc resection of bladder tumour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer
Complete resection for non-muscle-invasive bladder cancer is defined as the absence of any malignancy upon second-look transurethral resection surgery, in patients who have non-muscle-invasive bladder cancer upon the first modified en bloc resection. Proper staging for muscle-invasive bladder cancer is defined as the detection of muscle-invasive bladder cancer upon the first modified en bloc resection, in all patients who have a definitive histological diagnosis of muscle-invasive bladder cancer upon modified en bloc resection or second-look transurethral resection surgery. Second look transurethral resection surgery is expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.
Measured: Seven weeks after the experimental operation
Secondary outcomes (13)
Proper staging rate for non-muscle-invasive bladder cancer
The proper staging rate for non-muscle-invasive bladder cancer is defined as the absence of any upstaging of the T-stage upon second-look transurethral resection surgery, in patients who have non-muscle-invasive bladder cancer upon the first modified en bloc resection. Second look transurethral resection surgery is expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.
Measured: Seven weeks after the experimental operation
Complete resection rate for muscle-invasive bladder cancer
The complete resection rate for muscle-invasive bladder cancer is defined as the absence of any malignancy upon second-look transurethral resection surgery or radical surgery, in patients who have muscle-invasive bladder cancer upon the first modified en bloc resection. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.
Measured: Seven weeks after the experimental operation
Successful modified en bloc resection rate
Techical success rate of modified en bloc resection
Measured: Immediately post-operative
Negative circumferential resection margin rate
Rate of negative circumferential resection margin of the modified en bloc resection pathological specimen
Measured: One week after the experimental operation
Negative deep resection margin rate
Rate of negative deep resection margin of the modified en bloc resection pathological specimen
Measured: One week after the experimental operation
Detrusor muscle sampling rate
Rate of presence of detrusor muscle in the modified en bloc resection pathological specimen
Measured: One week after the experimental operation
Occurrence of obturator reflex
Number of participants with obturator reflex encountered by the operating surgeon during the modified en bloc resection operation
Measured: Intra-operative
Operative time
Duration of operation
Measured: Immediately post-operative
Rate of mitomycin C instillation
One day after the experimental operation
Measured: Immediately post-operative
Duration of bladder irrigation
Duration of bladder irrigation. Patients undergoing transurethral resection surgery have an average hospital stay of three days. Bladder irrigation is always stopped before the patient is discharged
Measured: Three days after the experimental operation.
Duration of urethral catheterisation
Duration of urethral catheterisation. Patients undergoing transurethral resection surgery have an average hospital stay of three days. Urethral catheter is often removed before the patient is discharged
Measured: Three days after the experimental operation
Hospital stay
Patients undergoing transurethral resection surgery have an average hospital stay of three days.
Measured: Three days after the experimental operation
30-day complications
Complications which occur within 30 days after the operation
Measured: Thirty days after the experimental surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start7 Sep 2020
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Yuen Chun TEOH, Chinese University of Hong Kong
- Investigators
- Jeremy YC Teoh, MBBS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081246
- Sponsor's protocol ID
- CREC 2018.580-T
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.
PubMed 10687997Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19.
PubMed 20303646Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
PubMed 27324428Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.
PubMed 11157016
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Modified En Bloc Resection For Large Bladder Tumours.
- ClinicalTrials.gov ID
- NCT04081246
- Acronym / sponsor ID
- CREC 2018.580-T
- Conditions
- Bladder Cancer, Bladder Neoplasm, Bladder Tumor
- Keywords
- Bladder cancer, bladder tumour, en bloc resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 9 Sep 2019 (actual)
- 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.
Modified en bloc resection is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. In this study, we shall investigate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm in size.
Detailed description
The biggest limiting factor of en bloc resection is the size of the bladder tumour. Resection of the bladder tumour is technically feasible, but the retrieval of specimen in one piece is restricted by the narrow size of the urethra. However, the greatest advantage of en bloc resection is to ensure complete local resection rather than the theoretical benefit of avoiding tumour re-implantation. Therefore, the concept of modified en bloc resection for large bladder tumours of ≥3cm has evolved. It is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. By resecting the exophytic part of the bladder tumour, the size of main tumour bulk can be reduced. By performing en bloc resection of the tumour base, the advantage of ensuring complete tumour resection beneath the submucosal plane can be preserved, and the tumour base specimen remains intact for histological assessment of the resection margins. Modified en bloc resection is a promising surgical technique which can potentially ensure complete tumour resection, reduce the need of second-look transurethral resection, and improve the oncological control of non-muscle-invasive bladder cancer in long run. It may also ensure proper staging of muscle-invasive bladder cancer at the first surgery, thus avoiding the need of second-look transurethral resection in under-staged patients.
In this study, we shall evaluate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm. All patients will have MRI before modified en bloc resection. All patients with non-muscle-invasive bladder cancer will be offered second-look transurethral resection in 2-6 weeks' time. All patients with muscle-invasive bladder cancer but not distant metastasis will be offered radical cystectomy, pelvic lymphadenectomy and urinary diversion; for those who refuse or who are considered unfit for radical surgery, second-look transurethral resection will be offered. All patients will have a second MRI before the second surgery. The modified en bloc resection specimen results will be compared with the final pathology results in the second surgery. The presence of any residual or upstaging of disease will be determined. The results of the two sets of MRI will also be compared with the final pathology results. The accuracy of MRI in the evaluation of bladder cancer will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified en bloc resection | Experimental | Device: Bipolar transurethral modified en bloc resection of bladder tumourFor patients undergoing modified en bloc resection, piecemeal resection of the exophytic part of the bladder tumour will be performed, followed by en bloc resection of the tumour base. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 80 years old with informed consent
- Bladder tumours with maximal dimension of ≥ 3cm
Key exclusion criteria (10 listed)
- Bladder tumour detected during intravesical Bacillus Calmette-Guerin therapy (These patients warrant more aggressive treatment, i.e. radical cystectomy)
- Estimated glomerular filtration rate of <60mL/min.
- Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
- Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
- History of bleeding disorder or use of anti-coagulant
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 |
|---|---|---|
| Bipolar transurethral modified en bloc resection of bladder tumourOlympus TURis Bipolar HF-resection electrode (Model: WA22306D) | Device | Modified en bloc resection |
Primary outcome
Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer
Time frame: Seven weeks after the experimental operation
Complete resection for non-muscle-invasive bladder cancer is defined as the absence of any malignancy upon second-look transurethral resection surgery, in patients who have non-muscle-invasive bladder cancer upon the first modified en bloc resection. Proper staging for muscle-invasive bladder cancer is defined as the detection of muscle-invasive bladder cancer upon the first modified en bloc resection, in all patients who have a definitive histological diagnosis of muscle-invasive bladder cancer upon modified en bloc resection or second-look transurethral resection surgery. Second look transurethral resection surgery is expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.
13 secondary outcomes
Proper staging rate for non-muscle-invasive bladder cancer
Time frame: Seven weeks after the experimental operation
Complete resection rate for muscle-invasive bladder cancer
Time frame: Seven weeks after the experimental operation
Successful modified en bloc resection rate
Time frame: Immediately post-operative
Negative circumferential resection margin rate
Time frame: One week after the experimental operation
Negative deep resection margin rate
Time frame: One week after the experimental operation
Detrusor muscle sampling rate
Time frame: One week after the experimental operation
Occurrence of obturator reflex
Time frame: Intra-operative
Operative time
Time frame: Immediately post-operative
Rate of mitomycin C instillation
Time frame: Immediately post-operative
Duration of bladder irrigation
Time frame: Three days after the experimental operation.
Duration of urethral catheterisation
Time frame: Three days after the experimental operation
Hospital stay
Time frame: Three days after the experimental operation
30-day complications
Time frame: Thirty days after the experimental surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 10687997Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.
- Background: PubMed 20303646Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19.
- Background: PubMed 27324428Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
- Background: PubMed 11157016Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.
- Individual participant dataSharing planned: No
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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.
Jeremy YC Teoh, MBBS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar transurethral modified en bloc resection of bladder tumour in people with Bladder Cancer and Bladder Neoplasm, run by Chinese University of Hong Kong at 1 site 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 10 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer (time frame: Seven weeks after the experimental operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081246, which also lists 4 linked publications.
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 27 Oct 2026.