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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

NCT ID: NCT02951078

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Thulium Laser en Bloc Resection of bladder tumor

Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser

Group Type EXPERIMENTAL

Thulium Laser en Bloc Resection of bladder tumor

Intervention Type PROCEDURE

Electrical transurethral resection of bladder tumor

Electrical transurethral resection of the Non-muscle Invasive Bladder tumor

Group Type ACTIVE_COMPARATOR

Electrical transurethral resection of bladder tumor

Intervention Type PROCEDURE

Interventions

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Thulium Laser en Bloc Resection of bladder tumor

Intervention Type PROCEDURE

Electrical transurethral resection of bladder tumor

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Liu Haitao

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Haitao Liu, chief physician

Role: CONTACT

Phone: +86 15301655608

Email: [email protected]

Other Identifiers

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ChiCTR-INR-16009513

Identifier Type: -

Identifier Source: org_study_id