Bladder CancerPhase 3eBLOCNCT03718754
En-bloc vs Conventional Resection of Primary Bladder Tumor
A Phase 3 study testing En-Bloc TURB and Conventional TURB in people with Bladder Cancer, run by David D'Andrea at 1 site in Austria.
Trial summary
Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- En-Bloc TURB and Conventional TURB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteAustria
- Study dates
- 28 Feb 2019to 20 Jan 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all the following inclusion criteria to participate in this study:
- Diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial carcinoma (cTa, cT1)
- Imaging examinations shows that the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- Diameter of tumor between 1cm and 3cm
- Number of lesions ≤3 (The position of small lesions relatively concentrated as one place)
- Patients who agree to eTURB or cTURB surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation
Who cannot join
- Pure carcinoma in situ
- Contraindications to surgery (i.e. bladder fibrosis)
- Diameter of tumor >3cm
- Number of lesions >3
- Poor performance status making a surgical intervention too risky
- Life expectancy of less than one year
Show all 9Show fewer
- Patient refused to participate
- Pregnancy
- History of upper urinary tract malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.
To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.
- Conditions
- Bladder Cancer
- Being tested
- En-Bloc TURB, Conventional TURB
- 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 TURBDevice
En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
Conventional TURBDevice
En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
| Study group | Role | What they receive |
|---|---|---|
| En-Bloc TURB | Active comparator | Not described Receives: Device: En-Bloc TURB |
| Conventional TURB | Active comparator | Not described Receives: Device: Conventional TURB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological staging assessment for eTURB compared to cTURB
The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB
Measured: 4 weeks
Secondary outcomes (11)
Residual disease within 3 months after initial TURB
Measured: 3 months
Occurrence of obturator reflex
Measured: 1 day
Operative time
Measured: 1 day
Number of participants with bladder perforation
Measured: 7 days
Upstaging of disease upon second look transurethral resection surgery
Measured: 6 weeks
Number of participants with obturator reflex
Measured: 1 day
Number of tumors with evaluable lateral and deep resection margin
Measured: 4 weeks
Number of tumors with positive lateral and deep resection margin
Measured: 4 weeks
Number of participants with conversion to other resection technique
Measured: 1 day
Number of participants with persistent disease at 2nd look TURB
Measured: 6 weeks
Recurrence-free survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start28 Feb 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- David D'Andrea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David D'Andrea, Medical University of Vienna
- Investigators
- Shahrokh Shariat, M.D., Study chair, Shahrokh.shariat@meduniwien.ac.at
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718754
- Sponsor's protocol ID
- 1636/2018
- Acronym
- eBLOC
- Status last verified
- Mar 2023
- First submitted
- 23 Oct 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Andrea D, Soria F, Hurle R, Enikeev D, Kotov S, Regnier S, Xylinas E, Lusuardi L, Heidenreich A, Cai C, Frego N, Taraktin M, Ryabov M, Gontero P, Comperat E, Shariat SF; eBLOC Study Team. En Bloc Versus Conventional Resection of Primary Bladder Tumor (eBLOC): A Prospective, Multicenter, Open-label, Phase 3 Randomized Controlled Trial. Eur Urol Oncol. 2023 Oct;6(5):508-515. doi: 10.1016/j.euo.2023.07.010. Epub 2023 Aug 4.
PubMed 37543464
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT03718754
- Acronym / sponsor ID
- eBLOC / 1636/2018
- Conditions
- Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- David D'AndreaUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 24 Oct 2018 (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.
Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.
To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| En-Bloc TURB | Active comparator | Device: En-Bloc TURB |
| Conventional TURB | Active comparator | Device: Conventional TURB |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial carcinoma (cTa, cT1)
- Imaging examinations shows that the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- Diameter of tumor between 1cm and 3cm
- Number of lesions ≤3 (The position of small lesions relatively concentrated as one place)
- Patients who agree to eTURB or cTURB surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation
Key exclusion criteria (9 listed)
- Pure carcinoma in situ
- Contraindications to surgery (i.e. bladder fibrosis)
- Diameter of tumor >3cm
- Number of lesions >3
- Poor performance status making a surgical intervention too risky
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 TURBEn-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible. | Device | En-Bloc TURB |
| Conventional TURBEn-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible. | Device | Conventional TURB |
Primary outcome
The pathological staging assessment for eTURB compared to cTURB
Time frame: 4 weeks
The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB
11 secondary outcomes
Residual disease within 3 months after initial TURB
Time frame: 3 months
Occurrence of obturator reflex
Time frame: 1 day
Operative time
Time frame: 1 day
Number of participants with bladder perforation
Time frame: 7 days
Upstaging of disease upon second look transurethral resection surgery
Time frame: 6 weeks
Number of participants with obturator reflex
Time frame: 1 day
Number of tumors with evaluable lateral and deep resection margin
Time frame: 4 weeks
Number of tumors with positive lateral and deep resection margin
Time frame: 4 weeks
Number of participants with conversion to other resection technique
Time frame: 1 day
Number of participants with persistent disease at 2nd look TURB
Time frame: 6 weeks
Recurrence-free survival
Time frame: up to 5 years
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 Mar 2023.
- Derived from this study: PubMed 37543464D'Andrea D, Soria F, Hurle R, Enikeev D, Kotov S, Regnier S, Xylinas E, Lusuardi L, Heidenreich A, Cai C, Frego N, Taraktin M, Ryabov M, Gontero P, Comperat E, Shariat SF; eBLOC Study Team. En Bloc Versus Conventional Resection of Primary Bladder Tumor (eBLOC): A Prospective, Multicenter, Open-label, Phase 3 Randomized Controlled Trial. Eur Urol Oncol. 2023 Oct;6(5):508-515. doi: 10.1016/j.euo.2023.07.010. Epub 2023 Aug 4.
- 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.
Shahrokh Shariat, M.D. study chair
Shahrokh.shariat@meduniwien.ac.at
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing En-Bloc TURB and Conventional TURB in people with Bladder Cancer, run by David D'Andrea at 1 site in Austria.
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 9 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 Mar 2023. 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 Austria. 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?
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?
The pathological staging assessment for eTURB compared to cTURB (time frame: 4 weeks). 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 NCT03718754, which also lists 1 linked publication.
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 Mar 2023.