Non-muscle Invasive Bladder CancerNCT05223491
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer
A study testing En Bloc resection and Conventional TURB in people with Non-muscle Invasive Bladder Cancer, run by Jørgen Bjerggaard Jensen at 11 sites in 5 countries.
Trial summary
Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- En Bloc resection and Conventional TURB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 17 Mar 2022to 19 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demographics: all BMI, smokers and non-smokers
- Primary, papillary, non-solid bladder tumour visualised by flexible cystoscopy
- Tumour diameter measured on CT-scan ≥2cm ≤6cm at largest diameter
- Ability to fully comprehend the information provided and comply with protocol
- Signed consent form
- Patients with multiple tumours can be included if it seems feasible to resect them in one procedure
Who cannot join
- Clinically suspected muscle invasive bladder cancer (invasion in to bladder muscle or extravesical extension visible on CT or solid tumour without papillary elements seen at cystoscopy)
- Tumour located in a bladder diverticulum
- Investigating physician concludes that en bloc resection is not technically possible
- Pregnancy
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Denmark7 sites
Department of Urology, Aalborg University Hospital
Aalborg, 9100
Department of Urology, Aarhus University Hospital
Aarhus, 8200
Department of Urology, Herlev Hospital
Herlev
Department of Urology, Regional Hospital Gødstrup
Holstebro, 7500
Department of Urology, Odense University Hospital
Odense, 5000
Department of Urology, Zealand University Hospital
Roskilde, 4000
Dept. of Urology, Hospital Lilelbælt, Vejle
Vejle, 7100
Latvia1 site
Urological Center, Paula Stradina Clinical University Hospital
Riga, LV-1002
About this study
Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty.
Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed.
Read more
Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022.
Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- En Bloc resection, Conventional TURB
- Keywords
- en bloc, TURB
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En Bloc resectionProcedure or surgery
Tumour is resected and removed from the bladder in one piece, if possible.
Conventional TURBProcedure or surgery
Tumour is resected piecemeal.
| Study group | Role | What they receive |
|---|---|---|
| En Bloc | Experimental | The bladder tumour will be resected en bloc and removed in total, if possible. Receives: Procedure: En Bloc resection |
| Conventional TURB | Active comparator | The bladder tumour will be removed by conventional piecemeal resection. Receives: Procedure: Conventional TURB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaltered pathological T-stage
Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.
Measured: 4 months
Secondary outcomes (2)
Detrusor muscle in specimen
Prevalence of detrusor muscle in specimen by pathological examination
Measured: Within one week from surgery
Recurrence free survival
Proportion of patients with recurrences at 4 months follow-up cystoscopy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start17 Mar 2022
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Novo Nordisk Foundation
- Responsible party
- Sponsor-investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223491
- Sponsor's protocol ID
- En Bloc
- Status last verified
- Sep 2024
- First submitted
- 7 Jan 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05223491
- Acronym / sponsor ID
- En Bloc
- Conditions
- Non-muscle Invasive Bladder Cancer
- Keywords
- en bloc, TURB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Jørgen Bjerggaard JensenUniversity, hospital or other
- Collaborators
- University of Aarhus, Novo Nordisk Foundation
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 4 Feb 2022 (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.
Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty.
Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed.
Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022.
Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| En Bloc | Experimental | Procedure: En Bloc resectionThe bladder tumour will be resected en bloc and removed in total, if possible. |
| Conventional TURB | Active comparator | Procedure: Conventional TURBThe bladder tumour will be removed by conventional piecemeal resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Demographics: all BMI, smokers and non-smokers
- Primary, papillary, non-solid bladder tumour visualised by flexible cystoscopy
- Tumour diameter measured on CT-scan ≥2cm ≤6cm at largest diameter
- Ability to fully comprehend the information provided and comply with protocol
- Signed consent form
Key exclusion criteria (4 listed)
- Clinically suspected muscle invasive bladder cancer (invasion in to bladder muscle or extravesical extension visible on CT or solid tumour without papillary elements seen at cystoscopy)
- Tumour located in a bladder diverticulum
- Investigating physician concludes that en bloc resection is not technically possible
- 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 resectionTumour is resected and removed from the bladder in one piece, if possible. | Procedure or surgery | En Bloc |
| Conventional TURBTumour is resected piecemeal. | Procedure or surgery | Conventional TURB |
Primary outcome
Unaltered pathological T-stage
Time frame: 4 months
Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.
2 secondary outcomes
Detrusor muscle in specimen
Time frame: Within one week from surgery
Recurrence free survival
Time frame: 4 months
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 16 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing En Bloc resection and Conventional TURB in people with Non-muscle Invasive Bladder Cancer, run by Jørgen Bjerggaard Jensen at 11 sites in 5 countries.
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 6 inclusion and 4 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark, Estonia, Finland, Latvia, Norway. 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?
Unaltered pathological T-stage (time frame: 4 months). 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 16 Jan 2026.