Clinical trial · Interventional
En-Bloc Resection of Bladder Tumors
En-Bloc Resection of Bladder Tumors: a Multicentric Safety and Feasibility Trial (IDEAL Phase II) vs Conventional Resection of Bladder Tumors?
- 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)
Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage. Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging. Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival. Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.
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 Neoplasm | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) | Procedure | — | UNRESOLVED |
| En Bloc Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- En Bloc Resection Bladder Tumor (Any energy source)
- description
- Patients with suspicion of NMIBC (primary or recurrent) that underwent en bloc resection (EBRT
- interventionNames
- Procedure: En Bloc Resection
- type
- ACTIVE_COMPARATOR
- label
- Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
- description
- Patients with suspicion of NMIBC (primary or recurrent) that underwent conventional TURBT
- interventionNames
- Procedure: Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
Primary outcomes (2)
- measure
- Pathological Staging
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 years old and older (adult, older adult) Sexes: All Accepts healthy volunteers: No Inclusion criteria: * Patients aged 18 and older presenting with suspicion of primary or recurrent Non-muscle invasive bladder cancer (NMIBC) * Tumor size estimated by cystoscopy ≤ 3 cm * Solitary or multiple tumors (up to 3 in number) Exclusion Criteria: * Tumor size \> 3 cm of maximum dimeter * Patient with severe systemic disease (ASA III+) * Location on the anterior bladder wall and/ or anterior bladder neck (relative contraindication depending on accessibility) * Pregnancy * Histological diagnosis other than NMIBC urothelial bladder cancer * Presence or history of previous upper-tract urinary cancer (UTUC) * Presence of positive cytology without macroscopic identifiable bladder tumor * Life expectancy \< 1 year * Non-reversible coagulopathy * Bladder tumor detected during intravesical BCG therapy * Tumor multiplicity (\> 3 tumors) Contacts and locations:
References
Publications (0)
Data not yet available