Clinical trial · Interventional
Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
- 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)
According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely. Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.
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 |
|---|---|---|---|
| en bloc resection, morcellation | Procedure | — | UNRESOLVED |
| piecemeal resection, tissue removal by loop | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- en bloc resection group
- description
- Patients scheduled for laser en bloc tumor resection with subsequent morcellation of exophytic part of the tumor
- interventionNames
- Procedure: en bloc resection, morcellation
- type
- EXPERIMENTAL
- label
- piecemeal resection group
- description
- Patients scheduled for piecemeal bladder tumor TUR with subsequent removing of tissue using the instrument loop or Janet's syringe.
- interventionNames
- Procedure: piecemeal resection, tissue removal by loop
Primary outcomes (1)
- measure
- Recurrence free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients scheduled for endoscopic bladder tumor removal 2. Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 and lower) 3. Diameter of tumor \>3cm Exclusion Criteria: 1. Patient refused to participate in the trial 2. Multiple (more than 2) bladder tumors 3. Previous cold-cup biopsy or any other surgery for bladder tumor 4. Muscle-invasive bladder cancer on postoperative histological evaluation 5. Other malignant/benign tumors of the bladder (non-urothelial cancer)
References
Publications (0)
Data not yet available