Clinical trial · Observational
Can Second Resection for pT1 Bladder Cancer be Avoided After Initial En-Bloc Resection With Negative Safety Margins
Can Second Resection for pT1 Bladder Carcinoma be Safely Avoided After Initial En-Bloc Resection With Negative Vertical and Horizontal Safety Margins: A Randomized Controlled 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)
The goal of this \[ Can second resection for pT1 bladder carcinoma be safely avoided after initial En-Bloc Resection with negative vertical and horizontal safety margins ? is to assess the impact of avoiding re TUR on Recurrence free survival, progression free survival and cancer specific survival in patients with pT1 bladder cancer treated with ERBT and intravesical BCG through a RCT.
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 Stage I | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avoid second resection after initial complete resection | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Re_TUR
- description
- Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins will undergo second look as endorsed by the guidelines.
- interventionNames
- Behavioral: Avoid second resection after initial complete resection
- label
- No re_TUR
- description
- Those patients diagnosed with pT1 after initial ERBT with negative vertical and horizontal safety margins won't undergo second look as endorsed by the guidelines and will receive directly intravesical BCG
- interventionNames
- Behavioral: Avoid second resection after initial complete resection
Primary outcomes (1)
- measure
- Impact of avoiding repeat resection on recurrence and progression free survival.
- timeFrame
- 12 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: • Patients treated with ERBT and diagnosed with pT1 disease with negative vertical and horizontal safety margins at final pathology. Exclusion Criteria: * Large tumors not suitable for ERBT * Residual tumor. * Multicentric tumors ( more than 4 lesions) * Presence of CIS. * Positive vertical or horizontal safety margins after initial resection.
References
Publications (0)
Data not yet available