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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02951078

Enrollment

172

Registered

2016-11-01

Start date

2017-01-31

Completion date

Unknown

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

PROCEDUREThulium Laser en Bloc Resection of bladder tumor

PROCEDUREElectrical transurethral resection of bladder tumor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

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.

Design outcomes

Primary

Measure	Time frame
The residual rate of tumor in the second operation of the two surgical methods	2 years

Contacts

Primary ContactHaitao Liu, chief physician

doctorlht69@163.com+86 15301655608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026