Prospective, randomized, interventional, multi-center, single-blinded phase III clinical trial on the use of en-bloc mucosec-tomy technique (ERBT) or conventional transurethral resection of bladder tumors (TURBT) in patients with first appearance of non-muscle invasive bladder tumors (NMIBC)- EBRUC II trial

Not Applicable

Recruiting

Conditions: C67
Malignant neoplasm of bladder

Registration Number: DRKS00020738

Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Lübeck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 360

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objectives of this study is <br>(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<br>(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 Outcome Measures

Name	Time	Method
-Progression rate, defined as higher T- or G-stage<br>-Percentage of residual tumors during second TURB performed after 2-6 weeks (if indicated)<br>-Tumor extraction methods (flushing out, grasper, endo-bag etc.)<br>-Number of ERBT tumors that need to be dissected secondarily for re-moval<br>-Comparison of safety and bleeding rate by using Clavien-Dindo-classification and postoperative hemoglobin controls<br>-Histopathological assessability by lamina propria subclassification (T1-substaging)<br>-Horizontical and vertical R1-Status (resection margins) in both groups<br>-Long time recurrence after 24 months