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

Bladder Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02951078
• Other study ID #: ChiCTR-INR-16009513
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 23, 2016
• Last updated: October 31, 2016
• Start date: January 2017

Study information

• Verified date: October 2016
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Haitao Liu, chief physician
• Phone: +86 15301655608
• Email: doctorlht69[@]163.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Thulium Laser en Bloc Resection of bladder tumor

• Electrical transurethral resection of bladder tumor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The residual rate of tumor in the second operation of the two surgical methods		2 years	Yes