Clinical trial · Interventional
Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer
- 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)
This study is a prospective randomized controlled trial comparing holmium laser en-bloc resection of bladder tumor (HoLERBT) with conventional transurethral resection of bladder tumor (cTURBT) in patients with suspected non-muscle-invasive bladder cancer (NMIBC). A total of 100 patients will be randomly assigned in a 1:1 ratio to undergo either HoLERBT or cTURBT. The primary outcome is the quality of the pathological specimen, assessed by the presence of detrusor muscle. Secondary outcomes include perioperative complications, operative time, obturator nerve reflex, bladder perforation, positive surgical margins, persistent disease at second-look TURBT, and recurrence rates at 3 and 12 months, as well as recurrence-free survival. This study aims to evaluate whether HoLERBT provides superior resection quality and improved clinical outcomes compared to 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 Tumor (TURBT) | Bladder Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Transurethral Resection of Bladder Tumor | Procedure | — | UNRESOLVED |
| Holmium Laser En-Bloc Resection of Bladder Tumor | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Holmium Laser En-Bloc Resection (HoLERBT)
- description
- Patients in this group will undergo holmium laser en-bloc resection of bladder tumor (HoLERBT). The procedure involves complete tumor excision in a single piece using a holmium laser, allowing improved specimen quality and better hemostasis.
- interventionNames
- Procedure: Holmium Laser En-Bloc Resection of Bladder Tumor
- type
- ACTIVE_COMPARATOR
- label
- Conventional TURBT
- description
- Patients in this group will undergo conventional transurethral resection of bladder tumor (cTURBT), performed using standard resection techniques with a monopolar or bipolar resectoscope.
- interventionNames
- Procedure: Conventional Transurethral Resection of Bladder Tumor
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 30 years or older. * Patients with cystoscopically suspected primary NMIBC planned for endoscopic resection. * Fit for surgery and anesthesia. * Able and willing to provide written informed consent and comply with follow-up. Exclusion Criteria: * Muscle-invasive disease suspected preoperatively or evidence of metastatic disease. * Prior bladder radiotherapy. * Severe comorbidity precluding surgery. * Pregnancy. * Inability to provide informed consent. * Upper urinary tract urothelial carcinoma or life expectancy less than 1 year
References
Publications (0)
Data not yet available