En-bloc vs Conventional Resection of Primary Bladder Tumor (eBLOC)

En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: En-Bloc TURB; Device: Conventional TURB

• Study Type: Interventional
• Enrollment (Actual): 384
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: En-Bloc TURB	Device: En-Bloc TURB; 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.
Active Comparator: Conventional TURB	Device: Conventional TURB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative time	1 day
Residual disease within 3 months after initial TURB	3 months
Occurrence of obturator reflex	1 day
Number of participants with bladder perforation	7 days
Upstaging of disease upon second look transurethral resection surgery	6 weeks
Number of participants with obturator reflex	1 day
Number of tumors with evaluable lateral and deep resection margin	4 weeks
Number of tumors with positive lateral and deep resection margin	4 weeks
Number of participants with conversion to other resection technique	1 day
Number of participants with persistent disease at 2nd look TURB	6 weeks
Recurrence-free survival	up to 5 years

Collaborators and Investigators

• Sponsor: David D'Andrea
• Investigators: Study Chair: Shahrokh Shariat, M.D., Shahrokh.shariat@meduniwien.ac.at

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 1636/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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