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

Phase 3

• Conditions: Bladder Cancer
• Interventions: Procedure: Thulium Laser en Bloc Resection of bladder tumor; Procedure: Electrical transurethral resection of bladder tumor

• Registration Number: NCT02951078
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-23
• Study First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01
• Study Start: 2017-01
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 172

Inclusion Criteria

1. Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1);
2. Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
3. Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation;
4. Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2;
5. Bladder capacity≥ 200ml.

Exclusion Criteria

1. Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder;
2. Received chemotherapy or BCG perfusion therapy in the nearly 3 months;
3. Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms);
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thulium Laser en Bloc Resection of bladder tumor	Thulium Laser en Bloc Resection of bladder tumor	Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser
Electrical transurethral resection of bladder tumor	Electrical transurethral resection of bladder tumor	Electrical transurethral resection of the Non-muscle Invasive Bladder tumor

Primary Outcome Measures

Name	Time	Method
The residual rate of tumor in the second operation of the two surgical methods	2 years