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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| En-Bloc TURB | Active Comparator |
| |
| Conventional TURB | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| En-Bloc TURB | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Residual disease within 3 months after initial TURB | 3 months | |
| Occurrence of obturator reflex | 1 day | |
| Operative time |
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Inclusion Criteria
Subjects must meet all the following inclusion criteria to participate in this study:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Shahrokh Shariat, M.D. | Shahrokh.shariat@meduniwien.ac.at | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37543464 | Derived | 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. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Conventional TURB | Device | 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. |
|
| 1 day |
| Number of participants with bladder perforation | 7 days |
| Upstaging of disease upon second look transurethral resection surgery | 6 weeks |
| Number of participants with obturator reflex | 1 day |
| Number of tumors with evaluable lateral and deep resection margin | 4 weeks |
| Number of tumors with positive lateral and deep resection margin | 4 weeks |
| Number of participants with conversion to other resection technique | 1 day |
| Number of participants with persistent disease at 2nd look TURB | 6 weeks |
| Recurrence-free survival | up to 5 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |