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

David D'Andrea

Status and phase

Completed

Phase 3

Conditions

Bladder Cancer

Treatments

Device: Conventional TURB

Device: En-Bloc TURB

Study type

Interventional

Funder types

Other

Identifiers

NCT03718754

1636/2018

Details and patient eligibility

About

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.

Enrollment

384 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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