C67
Conditions
Interventions
Group 1: cTURBT (conventional transurethral resection of bladder tumour)
Group 2: ERBT (en bloc resection of bladder tumour)
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Key inclusion criteria: 1. Patients presenting for the first time with non-invasive bladder tumors (Ta low grade, Ta high grade, T1 low grade, T1 high grade) with a size bigger than one standard resection sling (4.3mm +-0.1) 2. Papillary bladder carcinoma which can be accessed for ERBT. 3. Positive results for tumors obtained by at least one of the following methods: cystoscopy, sonography, x-ray or positive cytology result for bladder cells. 4. All tumors of the patient could be resected by ERBT and TURBT.
Exclusion criteria
Exclusion criteria: Key exclusion criteria: 1. Patients with prior TURBT and recurrent tumors. 2. Patients with bladder tumor of stage T2. 3. Lesions and tumors that will not allow employing the dissection en-bloc such as solid or extensive multiple carcinomas. 4. Tumours which can be resected antegrade by one single cut of the re-section sling (standard sling size Karl Storz: 4.3mm +-0.1mm) have to be excluded from the study. There will be no upper limit for tumour size, as long as ERBT is feasible. 5. All primary CIS will be excluded from study. Accompanying CIS can be included. In these cases, recurrent tumours have to be precisely documented as in field or out field recurrences.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of this study is (i) to demonstrate that tumor resection using ERBT is as effective as conven-tional TURBT with respect to the proportion of in field or out field recurrent bladder tumors over a 1-year-period and (ii) to demonstrate that the proportion of specimens of resected bladder tumors that include tunica muscularis (TM) as identified during the histopathological examination is higher with ERBT than with TURBT. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression rate, defined as higher T- or G-stage - Percentage of residual tumors during second TURB performed after 2-6 weeks (if indicated) - Tumor extraction methods (flushing out, grasper, endo-bag etc.) - Number of ERBT tumors that need to be dissected secondarily for re-moval - Comparison of safety and bleeding rate by using Clavien-Dindo-classification and postoperative hemoglobin controls - Histopathological assessability by lamina propria subclassification (T1-substaging) - Horizontical and vertical R1-Status (resection margins) in both groups - Long time recurrence after 24 months | — |
Countries
Austria, Czechia, Germany, Italy
Contacts
Public ContactJulian Peter Struck
Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Outcome results
None listed