Back to resultsEn-bloc vs Conventional Resection of Primary Bladder Tumor (eBLOC)
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
En-Bloc TURB
Conventional TURB
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria
Subjects must meet all the following inclusion criteria to participate in this study:
- Diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial carcinoma (cTa, cT1)
- Imaging examinations shows that the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
- Diameter of tumor between 1cm and 3cm
- Number of lesions ≤3 (The position of small lesions relatively concentrated as one place)
- Patients who agree to eTURB or cTURB surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation
Exclusion Criteria
- Pure carcinoma in situ
- Contraindications to surgery (i.e. bladder fibrosis)
- Diameter of tumor >3cm
- Number of lesions >3
- Poor performance status making a surgical intervention too risky
- Life expectancy of less than one year
- Patient refused to participate
- Pregnancy
- History of upper urinary tract malignancy
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
En-Bloc TURB
Conventional TURB
Arm Description
Outcomes
Primary Outcome Measures
The pathological staging assessment for eTURB compared to cTURB
The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB
Secondary Outcome Measures
Residual disease within 3 months after initial TURB
Occurrence of obturator reflex
Operative time
Number of participants with bladder perforation
Upstaging of disease upon second look transurethral resection surgery
Number of participants with obturator reflex
Number of tumors with evaluable lateral and deep resection margin
Number of tumors with positive lateral and deep resection margin
Number of participants with conversion to other resection technique
Number of participants with persistent disease at 2nd look TURB
Recurrence-free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03718754
Brief Title
En-bloc vs Conventional Resection of Primary Bladder Tumor
Acronym
eBLOC
Official Title
En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David D'Andrea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.
To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
En-Bloc TURB
Arm Type
Active Comparator
Arm Title
Conventional TURB
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
En-Bloc TURB
Intervention Description
En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
Intervention Type
Device
Intervention Name(s)
Conventional TURB
Intervention Description
En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
Primary Outcome Measure Information:
Title
The pathological staging assessment for eTURB compared to cTURB
Description
The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Residual disease within 3 months after initial TURB
Time Frame
3 months
Title
Occurrence of obturator reflex
Time Frame
1 day
Title
Operative time
Time Frame
1 day
Title
Number of participants with bladder perforation
Time Frame
7 days
Title
Upstaging of disease upon second look transurethral resection surgery
Time Frame
6 weeks
Title
Number of participants with obturator reflex
Time Frame
1 day
Title
Number of tumors with evaluable lateral and deep resection margin
Time Frame
4 weeks
Title
Number of tumors with positive lateral and deep resection margin
Time Frame
4 weeks
Title
Number of participants with conversion to other resection technique
Time Frame
1 day
Title
Number of participants with persistent disease at 2nd look TURB
Time Frame
6 weeks
Title
Recurrence-free survival
Time Frame
up to 5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Subjects must meet all the following inclusion criteria to participate in this study:
Diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial carcinoma (cTa, cT1)
Imaging examinations shows that the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
Diameter of tumor between 1cm and 3cm
Number of lesions ≤3 (The position of small lesions relatively concentrated as one place)
Patients who agree to eTURB or cTURB surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation
Exclusion Criteria
Pure carcinoma in situ
Contraindications to surgery (i.e. bladder fibrosis)
Diameter of tumor >3cm
Number of lesions >3
Poor performance status making a surgical intervention too risky
Life expectancy of less than one year
Patient refused to participate
Pregnancy
History of upper urinary tract malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrokh Shariat, M.D.
Organizational Affiliation
Shahrokh.shariat@meduniwien.ac.at
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
En-bloc vs Conventional Resection of Primary Bladder Tumor
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