En-bloc vs Conventional Resection of Primary Bladder Tumor

NCT ID: NCT03718754

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2021-01-20

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

En-Bloc TURB

Group Type: ACTIVE_COMPARATOR

En-Bloc TURB

Intervention Type: DEVICE

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.

Conventional TURB

Group Type: ACTIVE_COMPARATOR

Conventional TURB

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David D'Andrea

OTHER

Sponsor Role: lead

Responsible Party

David D'Andrea

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shahrokh Shariat, M.D.

Role: STUDY_CHAIR

Shahrokh.shariat@meduniwien.ac.at

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

D'Andrea D, Soria F, Hurle R, Enikeev D, Kotov S, Regnier S, Xylinas E, Lusuardi L, Heidenreich A, Cai C, Frego N, Taraktin M, Ryabov M, Gontero P, Comperat E, Shariat SF; eBLOC Study Team. En Bloc Versus Conventional Resection of Primary Bladder Tumor (eBLOC): A Prospective, Multicenter, Open-label, Phase 3 Randomized Controlled Trial. Eur Urol Oncol. 2023 Oct;6(5):508-515. doi: 10.1016/j.euo.2023.07.010. Epub 2023 Aug 4.

Reference Type: DERIVED

PMID: 37543464 (View on PubMed)

Other Identifiers

1636/2018

Identifier Type: -

Identifier Source: org_study_id