En-bloc vs Conventional Resection of Primary Bladder Tumor

David D'Andrea384 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

384

Conditions

Bladder Cancer

Interventions

En-Bloc TURBDEVICE

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 TURBDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

Residual disease within 3 months after initial TURB

Time frame: 3 months

Occurrence of obturator reflex

Time frame: 1 day

Operative time

Time frame: 1 day

Number of participants with bladder perforation

Time frame: 7 days

Upstaging of disease upon second look transurethral resection surgery

Time frame: 6 weeks

Number of participants with obturator reflex

Time frame: 1 day

Number of tumors with evaluable lateral and deep resection margin

Time frame: 4 weeks

Number of tumors with positive lateral and deep resection margin

Time frame: 4 weeks

Number of participants with conversion to other resection technique

Time frame: 1 day

Number of participants with persistent disease at 2nd look TURB

Time frame: 6 weeks

Data from ClinicalTrials.gov

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