Back to resultsA Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Thulium Laser en Bloc Resection of bladder tumor
Electrical transurethral resection of bladder tumor
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thulium Laser en Bloc Resection of bladder tumor
Electrical transurethral resection of bladder tumor
Arm Description
Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser
Electrical transurethral resection of the Non-muscle Invasive Bladder tumor
Outcomes
Primary Outcome Measures
The residual rate of tumor in the second operation of the two surgical methods
Secondary Outcome Measures
Full Information
NCT ID
NCT02951078
First Posted
October 23, 2016
Last Updated
October 31, 2016
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02951078
Brief Title
A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thulium Laser en Bloc Resection of bladder tumor
Arm Type
Experimental
Arm Description
Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser
Arm Title
Electrical transurethral resection of bladder tumor
Arm Type
Active Comparator
Arm Description
Electrical transurethral resection of the Non-muscle Invasive Bladder tumor
Intervention Type
Procedure
Intervention Name(s)
Thulium Laser en Bloc Resection of bladder tumor
Intervention Type
Procedure
Intervention Name(s)
Electrical transurethral resection of bladder tumor
Primary Outcome Measure Information:
Title
The residual rate of tumor in the second operation of the two surgical methods
Time Frame
2 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haitao Liu, chief physician
Phone
+86 15301655608
Email
doctorlht69@163.com
12. IPD Sharing Statement
Learn more about this trial
A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
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