Clinical trial · Interventional
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
NCT04081246CI-TRIAL-00118896completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Modified en bloc resection is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. In this study, we shall investigate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm in size.
Conditions
Conditions (3)
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 |
| Bladder Neoplasm | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Bladder Tumor | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bipolar transurethral modified en bloc resection of bladder tumour | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified en bloc resection
- description
- For patients undergoing modified en bloc resection, piecemeal resection of the exophytic part of the bladder tumour will be performed, followed by en bloc resection of the tumour base.
- interventionNames
- Device: Bipolar transurethral modified en bloc resection of bladder tumour
Primary outcomes (1)
- measure
- Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer
- timeFrame
- Seven weeks after the experimental operation
- description
- Complete resection for non-muscle-invasive bladder cancer is defined as the absence of any malignancy upon second-look transurethral resection surgery, in patients who have non-muscle-invasive bladder cancer upon the first modified en bloc resection. Proper staging for muscle-invasive bladder cancer is defined as the detection of muscle-invasive bladder cancer upon the first modified en bloc resection, in all patients who have a definitive histological diagnosis of muscle-invasive bladder cancer upon modified en bloc resection or second-look transurethral resection surgery. Second look transurethral resection surgery is expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 80 years old with informed consent * Bladder tumours with maximal dimension of ≥ 3cm Exclusion Criteria: * Bladder tumour detected during intravesical Bacillus Calmette-Guerin therapy (These patients warrant more aggressive treatment, i.e. radical cystectomy) * Estimated glomerular filtration rate of \<60mL/min. * Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) * Presence of GOLD Stage III or IV chronic obstructive pulmonary disease * History of bleeding disorder or use of anti-coagulant * Presence of other active malignancy * ECOG performance status ≥ 2 (Ambulatory and capable of all self care but unable to carry our any work activities. Confined to bed or chair less than 50% of waking hours) * Pregnancy * Presence of metallic foreign body or implant which is not MRI compatible * Known history of claustrophobia
References
Publications (4)
- BACKGROUNDUkai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9. PMID 10687997
- BACKGROUNDDivrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19. PMID 20303646
- BACKGROUNDBabjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17. PMID 27324428
- BACKGROUNDStein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666. PMID 11157016