Clinical trial · Interventional
En-bloc vs Conventional Resection of Primary Bladder Tumor
En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional TURB | Device | — | UNRESOLVED |
| En-Bloc TURB | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- En-Bloc TURB
- interventionNames
- Device: En-Bloc TURB
- type
- ACTIVE_COMPARATOR
- label
- Conventional TURB
- interventionNames
- Device: Conventional TURB
Primary outcomes (1)
- measure
- The pathological staging assessment for eTURB compared to cTURB
- timeFrame
- 4 weeks
- description
- 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
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria 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 Exclusion Criteria * 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 * Patient refused to participate * Pregnancy * History of upper urinary tract malignancy
References
Publications (1)
- DERIVEDD'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. PMID 37543464