A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer

Study Overview
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Brief Summary
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This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Half of participants will receive thulium laser resection of bladder cancer, while the other half will receive electrical transurethral resection of bladder cancer.

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Thulium Laser en Bloc Resection of bladder tumor
* Procedure: Electrical transurethral resection of bladder tumor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1); Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis; Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation; Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2; Bladder capacity≥ 200ml. Exclusion Criteria: Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder; Received chemotherapy or BCG perfusion therapy in the nearly 3 months; Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms); Patients during pregnancy ,critical care patients and patients who have other cases of surgical contraindications.Such as serious cardiovascular disease,coagulation abnormalities,non-transitional epithelial tumors( such as adenocarcinoma and squamous cell carcinoma),acute cystitis,can not be supine because of spinal deformity,untreated urethral stricture.
Sexes Eligible for Study
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Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thulium Laser en Bloc Resection of bladder tumor<br>Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser | Procedure: Thulium Laser en Bloc Resection of bladder tumor<br> <br> |
| Active Comparator: Electrical transurethral resection of bladder tumor<br>Electrical transurethral resection of the Non-muscle Invasive Bladder tumor | Procedure: Electrical transurethral resection of bladder tumor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The residual rate of tumor in the second operation of the two surgical methods |  | 2 years |