Trial document




This trial has been registered retrospectively.
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  DRKS00020738

Trial Description

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Title

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

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Trial Acronym

EBRUC II

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URL of the Trial

https://www.uksh.de/urologie-luebeck/Informationen+f%C3%BCr+Patienten/Studienzentrale-p-748.html

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Brief Summary in Lay Language

The European Association of Urology section of Uro-Technology (ESUT) has started an initiative with the goal of providing data on ERBT. As a consequence, the EBRUC project (En Bloc Resection of Urothelial Carcinoma) was started. Phase 1 provided analyses based on retrospective data [5]. Phase 2 represents a European multi-institutional prospective, randomized study in which ERBT will be compared to conventional TURBT which the ambitious primary goal of showing non inferiority ac-cording to tumor recurrence. Secondary goals will provide information about feasibility, specimens’ quality, tumor retrieval and complications.

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Brief Summary in Scientific Language

Prospective, randomized, interventional, multi-center, single-blinded, urooncologic clinical trial comparing the en bloc resection technique and standard resection for bladder tumours.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

On demand and after investigator's approval.

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Organizational Data

  •   DRKS00020738
  •   2020/02/11
  •   [---]*
  •   yes
  •   Approved
  •   18-284, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   cTURBT (conventional transurethral resection of bladder tumour)
  •   ERBT (en bloc resection of bladder tumour)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
  •   Czech Republic
  •   Austria
  •   Italy
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/03/20
  •   360
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
    • Mr.  Dr. med.  Julian Peter  Struck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Deutschland
    • Mr.  Privatdozent Dr. med.  Mario Wolfgang  Kramer 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
    • Mr.  Dr. med.  Julian Peter  Struck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.