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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

Organizational Data

DRKS-ID:
DRKS00020738
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-02-11
Last update in DRKS:
2020-02-11
Registration type:
Retrospective

Acronym/abbreviation of the study

EBRUC II

URL of the study

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

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.

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.

Health condition or problem studied

ICD10:
C67 - Malignant neoplasm of bladder
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
cTURBT (conventional transurethral resection of bladder tumour)
Arm 2:
ERBT (en bloc resection of bladder tumour)

Endpoints

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.
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

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Czechia
  • Germany
  • Italy
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik und Poliklinik für Urologie und Kinderurologie Mainz
  • Medical center SLK Kliniken Heilbronn, Klinik für Urologie und Kinderurologie Heilbronn
  • Medical center Kliniken Maria Hilf GmbH, Klinik für Urologie Mönchengladbach
  • University medical center Klinik für Urologie Lübeck
  • Medical center Klinik und Poliklinik für Urologie Wolfsburg
  • University medical center Klinik für Urologie und Urologische Onkologie Hannover
  • University medical center Klinik für Urologie Prag
  • Medical center Humanitas Research Hospital Mailand

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2019-03-20
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
360
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
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.

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.

Addresses

Primary Sponsor

Universitätsklinikum Schleswig-Holstein Campus Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uk-sh.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Deutschland
Privatdozent Dr. med. Mario Wolfgang Kramer
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
0451 500 43601
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/Urologie_Luebeck

Contact for Public Queries

Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Dr. med. Julian Peter Struck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
0451 500 43601
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/Urologie_Luebeck

Principal Investigator

Klinik für Urologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Deutschland
Privatdozent Dr. med. Mario Wolfgang Kramer
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
0451 500 43601
Fax:
No Entry
Contact per E-Mail
URL:
https://www.uksh.de/Urologie_Luebeck

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Schleswig-Holstein Campus Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uk-sh.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Med. Fakultät der Universität zu Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
+49-451-5004639
Fax:
+49-451-5003026
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2018-11-01
Ethics committee number:
18-284
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-03-19

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
On demand and after investigator's approval.

Study protocol and other study documents

Study protocols:
Studienprotokoll EBRUC II
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry