A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer
1 other identifier
interventional
172
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedNovember 1, 2016
October 1, 2016
1.9 years
October 23, 2016
October 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The residual rate of tumor in the second operation of the two surgical methods
2 years
Study Arms (2)
Thulium Laser en Bloc Resection of bladder tumor
EXPERIMENTALThulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser
Electrical transurethral resection of bladder tumor
ACTIVE COMPARATORElectrical transurethral resection of the Non-muscle Invasive Bladder tumor
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
October 23, 2016
First Posted
November 1, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Last Updated
November 1, 2016
Record last verified: 2016-10