En-bloc vs Conventional Resection of Primary Bladder Tumor

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: En-Bloc TURB
* Device: Conventional TURB


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: En-Bloc TURB<br> | Device: En-Bloc TURB<br>* 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.<br>|
| Active Comparator: Conventional TURB<br> | Device: Conventional TURB<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Residual disease within 3 months after initial TURB |  | 3 months | 
| 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 | 
| 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 |