Bladder Cancer
Conditions
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.
Interventions
DEVICEEn-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.
DEVICEConventional 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.
Sponsors
David D'Andrea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pathological staging assessment for eTURB compared to cTURB | 4 weeks | 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
| Measure | Time frame |
|---|---|
| Occurrence of obturator reflex | 1 day |
| Operative time | 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 |
| Residual disease within 3 months after initial TURB | 3 months |
| 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 |
| Number of tumors with evaluable lateral and deep resection margin | 4 weeks |
Countries
Austria
Outcome results
None listed