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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Bladder Cancer

Treatments: Procedure: Electrical transurethral resection of bladder tumor; Procedure: Thulium Laser en Bloc Resection of bladder tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT02951078

ChiCTR-INR-16009513

Details and patient eligibility

About

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.

Enrollment: 172 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 2 patient groups

Thulium Laser en Bloc Resection of bladder tumor

Experimental group

Description:

Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser

Treatment:

Procedure: Thulium Laser en Bloc Resection of bladder tumor

Electrical transurethral resection of bladder tumor

Active Comparator group

Description:

Electrical transurethral resection of the Non-muscle Invasive Bladder tumor

Treatment:

Procedure: Electrical transurethral resection of bladder tumor