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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951078
Recruitment Status : Unknown
Verified October 2016 by Liu Haitao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Liu Haitao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Thulium Laser en Bloc Resection of bladder tumor Procedure: Electrical transurethral resection of bladder tumor Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Thulium

Arm Intervention/treatment
Experimental: Thulium Laser en Bloc Resection of bladder tumor
Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser
Procedure: Thulium Laser en Bloc Resection of bladder tumor
Active Comparator: Electrical transurethral resection of bladder tumor
Electrical transurethral resection of the Non-muscle Invasive Bladder tumor
Procedure: Electrical transurethral resection of bladder tumor



Primary Outcome Measures :
  1. The residual rate of tumor in the second operation of the two surgical methods [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951078


Contacts
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Contact: Haitao Liu, chief physician +86 15301655608 doctorlht69@163.com

Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Liu Haitao, Chief physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02951078    
Other Study ID Numbers: ChiCTR-INR-16009513
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases