Bladder CancerNCT04934540
The Global En Bloc Resection of Bladder Tumour Registry
An observational study of Bladder Cancer, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The study aims to collect data on ERBT globally in order to clarify its role in the management of bladder cancer over a 5-year observation period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- En bloc resection of bladder tumour
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jan 2020to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients who are diagnosed with bladder tumors upon flexible cystoscopy and planning for ERBT
Who may be able to join
- Adult patients >=18 years old with informed consent
- Presence of bladder tumour undergoing transurethral ERBT
Who cannot join
- Presence or previous history of upper tract urothelial carcinoma
- Presence of other active malignancy
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
North District Hospital
Hong Kong
Joseph KM Li
Joseph KM Li
- Recruiting
Prince of Wales Hospital
Hong Kong
Jeremy YC Teoh
Jeremy YC Teoh
About this study
The study aims to collect data on ERBT globally in order to clarify its role in the management of bladder cancer over a 5-year observation period.
Read the detailed description
Bladder cancer is a prevalent disease globally, and it is the 9th most commonly diagnosed cancer in men worldwide. It has a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. This disease represents a significant burden to the healthcare system.
Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) according to its depth of invasion. Conceptually, NMIBC is amenable to complete resection by transurethral resection of bladder tumour (TURBT) alone, while MIBC requires more aggressive treatment in the form of radical cystectomy. The gold standard in local staging is by histology, and this can be achieved by TURBT. However, conventional TURBT creates charred tissue chips in a piecemeal manner which may hinder pathologists' judgment of the tumour base clearance. Second-look TURBT has been shown to detect residual disease in 33-55% of the patients, and upstaging of disease in 4-45% of the patients following the first TURBT; it has also been shown to improve recurrence-free survival in patients with T1 non-muscle-invasive bladder cancer. In addition, tumour fragmentation and reimplantation may lead to early disease recurrence. All these highlighted the limitations of the conventional TURBT procedure.
Transurethral en bloc resection of bladder tumour (ERBT) represents a novel surgical technique in which the bladder tumour is resected in one piece. Theoretically, ERBT may prevent recurrence by minimizing the risk of tumour reimplantation and ensuring complete resection based on proper histological assessment. Although ERBT has been practised in many centres worldwide, there is a lack of high quality evidence in proving its superiority over conventional TURBT. Also, the optimal indications, best energy modality, the need for routine tumour base biopsy, intravesical chemotherapy, second-look TURBT and the optimal follow-up protocol remain uncertain for this technique. Therefore, there is a need for a well-planned prospective multi-centre study to evaluate the role of ERBT in the management of bladder cancer.
Investigators propose to conduct a prospective, multi-centre, registry study to expedite understanding of ERBT and to establish its role in management of bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- En bloc resection of bladder tumour
- Keywords
- En bloc resection of bladder tumour
- 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.
En bloc resection of bladder tumourProcedure or surgery
En bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ERBT | Patients who are diagnosed with bladder tumors and planning for ERBT. Receives: Procedure: En bloc resection of bladder tumour |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete tumour resection rate
Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins.
Measured: One weeks after the surgery
Recurrence-free survival for NMIBC
Recurrence-free survival for patients with non-muscle-invasive bladder cancer
Measured: Every 3 months for the first two years, and then every 6 months for the next three years.
Secondary outcomes (14)
Proper staging rate for NMIBC
The proper staging rate for NMIBC is defined as the absence of any upstaging of the T-stage upon second-look TURBT or radical surgery, in patients who have NMIBC upon the first ERBT. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen.
Measured: Seven weeks after the operation
Proper staging rate for MIBC
The proper staging for MIBC is defined as the detection of MIBC upon the first En bloc resection, in all patients who have a definitive histological diagnosis of MIBC upon second-look TURBT or radical surgery. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen
Measured: Seven weeks after the operation
Complete tumour resection rate for MIBC
The complete tumour resection rate for MIBC is defined as the absence of any malignancy upon second-look TURBT or radical surgery, in patients who have MIBC upon the first ERBT. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen
Measured: Seven weeks after the operation
Successful ERBT rate
Technical success rate of en bloc resection
Measured: Immediately post-operative
Negative circumferential resection margin rate
Rate of negative circumferential resection margin of the en bloc resection pathological specimen
Measured: One week after the operation
Negative deep resection margin rate
Rate of negative deep resection margin of the en bloc resection pathological specimen
Measured: One week after the operation
Detrusor muscle sampling rate
Rate of presence of detrusor muscle in the en bloc resection pathological specimen
Measured: One week after the operation
Occurrence of obturator reflex
Number of participants with obturator reflex encountered by the operating surgeon during the 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 surgery
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 operation
Hospital stay
Patients undergoing transurethral resection surgery have an average hospital stay of three days.
Measured: Three days after the operation
30-day complications
The 30-day complications will be graded according to the Clavien-Dindo classification
Measured: Thirty days after the operation
Progression-free survival
Progression-free survival
Measured: Every 3 months for the first two years, and then every 6 months for the next three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
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, FRCS(Ed) MBBS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934540
- Sponsor's protocol ID
- CRE 2020.369
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Grimm MO, Steinhoff C, Simon X, Spiegelhalder P, Ackermann R, Vogeli TA. Effect of routine repeat transurethral resection for superficial bladder cancer: a long-term observational study. J Urol. 2003 Aug;170(2 Pt 1):433-7. doi: 10.1097/01.ju.0000070437.14275.e0.
PubMed 12853793Divrik 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 20303646Jahnson S, Wiklund F, Duchek M, Mestad O, Rintala E, Hellsten S, Malmstrom PU. Results of second-look resection after primary resection of T1 tumour of the urinary bladder. Scand J Urol Nephrol. 2005;39(3):206-10. doi: 10.1080/00365590510007793-1.
PubMed 16127800Lazica DA, Roth S, Brandt AS, Bottcher S, Mathers MJ, Ubrig B. Second transurethral resection after Ta high-grade bladder tumor: a 4.5-year period at a single university center. Urol Int. 2014;92(2):131-5. doi: 10.1159/000353089. Epub 2013 Aug 23.
PubMed 23988813Vasdev N, Dominguez-Escrig J, Paez E, Johnson MI, Durkan GC, Thorpe AC. The impact of early re-resection in patients with pT1 high-grade non-muscle invasive bladder cancer. Ecancermedicalscience. 2012;6:269. doi: 10.3332/ecancer.2012.269. Epub 2012 Sep 18.
PubMed 22988482Simon R, Eltze E, Schafer KL, Burger H, Semjonow A, Hertle L, Dockhorn-Dworniczak B, Terpe HJ, Bocker W. Cytogenetic analysis of multifocal bladder cancer supports a monoclonal origin and intraepithelial spread of tumor cells. Cancer Res. 2001 Jan 1;61(1):355-62.
PubMed 11196186Babjuk 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 27324428Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
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
- The Global En Bloc Resection of Bladder Tumour Registry
- ClinicalTrials.gov ID
- NCT04934540
- Acronym / sponsor ID
- CRE 2020.369
- Conditions
- Bladder Cancer
- Keywords
- En bloc resection of bladder tumour
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 2021 (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.
The study aims to collect data on ERBT globally in order to clarify its role in the management of bladder cancer over a 5-year observation period.
Detailed description
Bladder cancer is a prevalent disease globally, and it is the 9th most commonly diagnosed cancer in men worldwide. It has a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. This disease represents a significant burden to the healthcare system.
Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) according to its depth of invasion. Conceptually, NMIBC is amenable to complete resection by transurethral resection of bladder tumour (TURBT) alone, while MIBC requires more aggressive treatment in the form of radical cystectomy. The gold standard in local staging is by histology, and this can be achieved by TURBT. However, conventional TURBT creates charred tissue chips in a piecemeal manner which may hinder pathologists' judgment of the tumour base clearance. Second-look TURBT has been shown to detect residual disease in 33-55% of the patients, and upstaging of disease in 4-45% of the patients following the first TURBT; it has also been shown to improve recurrence-free survival in patients with T1 non-muscle-invasive bladder cancer. In addition, tumour fragmentation and reimplantation may lead to early disease recurrence. All these highlighted the limitations of the conventional TURBT procedure.
Transurethral en bloc resection of bladder tumour (ERBT) represents a novel surgical technique in which the bladder tumour is resected in one piece. Theoretically, ERBT may prevent recurrence by minimizing the risk of tumour reimplantation and ensuring complete resection based on proper histological assessment. Although ERBT has been practised in many centres worldwide, there is a lack of high quality evidence in proving its superiority over conventional TURBT. Also, the optimal indications, best energy modality, the need for routine tumour base biopsy, intravesical chemotherapy, second-look TURBT and the optimal follow-up protocol remain uncertain for this technique. Therefore, there is a need for a well-planned prospective multi-centre study to evaluate the role of ERBT in the management of bladder cancer.
Investigators propose to conduct a prospective, multi-centre, registry study to expedite understanding of ERBT and to establish its role in management of bladder cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ERBT | – | Procedure: En bloc resection of bladder tumourPatients who are diagnosed with bladder tumors and planning for ERBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with bladder tumors upon flexible cystoscopy and planning for ERBT
Key inclusion criteria (2 listed)
- Adult patients >=18 years old with informed consent
- Presence of bladder tumour undergoing transurethral ERBT
Key exclusion criteria (3 listed)
- Presence or previous history of upper tract urothelial carcinoma
- Presence of other active malignancy
- Pregnancy
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 |
|---|---|---|
| En bloc resection of bladder tumourEn bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece | Procedure or surgery | Patients undergoing ERBT |
Primary outcome
The complete tumour resection rate
Time frame: One weeks after the surgery
Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins.
Recurrence-free survival for NMIBC
Time frame: Every 3 months for the first two years, and then every 6 months for the next three years.
Recurrence-free survival for patients with non-muscle-invasive bladder cancer
14 secondary outcomes
Proper staging rate for NMIBC
Time frame: Seven weeks after the operation
Proper staging rate for MIBC
Time frame: Seven weeks after the operation
Complete tumour resection rate for MIBC
Time frame: Seven weeks after the operation
Successful ERBT rate
Time frame: Immediately post-operative
Negative circumferential resection margin rate
Time frame: One week after the operation
Negative deep resection margin rate
Time frame: One week after the operation
Detrusor muscle sampling rate
Time frame: One week after the 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 operation
Hospital stay
Time frame: Three days after the operation
30-day complications
Time frame: Thirty days after the operation
Progression-free survival
Time frame: Every 3 months for the first two years, and then every 6 months for the next three years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 12853793Grimm MO, Steinhoff C, Simon X, Spiegelhalder P, Ackermann R, Vogeli TA. Effect of routine repeat transurethral resection for superficial bladder cancer: a long-term observational study. J Urol. 2003 Aug;170(2 Pt 1):433-7. doi: 10.1097/01.ju.0000070437.14275.e0.
- 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 16127800Jahnson S, Wiklund F, Duchek M, Mestad O, Rintala E, Hellsten S, Malmstrom PU. Results of second-look resection after primary resection of T1 tumour of the urinary bladder. Scand J Urol Nephrol. 2005;39(3):206-10. doi: 10.1080/00365590510007793-1.
- Background: PubMed 23988813Lazica DA, Roth S, Brandt AS, Bottcher S, Mathers MJ, Ubrig B. Second transurethral resection after Ta high-grade bladder tumor: a 4.5-year period at a single university center. Urol Int. 2014;92(2):131-5. doi: 10.1159/000353089. Epub 2013 Aug 23.
- Background: PubMed 22988482Vasdev N, Dominguez-Escrig J, Paez E, Johnson MI, Durkan GC, Thorpe AC. The impact of early re-resection in patients with pT1 high-grade non-muscle invasive bladder cancer. Ecancermedicalscience. 2012;6:269. doi: 10.3332/ecancer.2012.269. Epub 2012 Sep 18.
- Background: PubMed 11196186Simon R, Eltze E, Schafer KL, Burger H, Semjonow A, Hertle L, Dockhorn-Dworniczak B, Terpe HJ, Bocker W. Cytogenetic analysis of multifocal bladder cancer supports a monoclonal origin and intraepithelial spread of tumor cells. Cancer Res. 2001 Jan 1;61(1):355-62.
- 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 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Individual participant dataSharing planned: Undecided
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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.
Jeremy YC TEOH, FRCS(Ed) MBBS 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?
An observational study of Bladder Cancer, 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 3 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: looking for participants now, 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy YC TEOH, FRCS(Ed) MBBS (852-35052625, jeremyteoh@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete tumour resection rate (time frame: One weeks after the surgery). 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?
On the ClinicalTrials.gov record for NCT04934540, which also lists 9 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.