A Study of Comparing Effects of Thulium Laser en Bloc Res... | NCT02951078

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

NCT02951078

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Nov 1, 2016Estimated

Enrollment

172Estimated

Phase

Phase 3

Conditions

Bladder Cancer

Interventions

Thulium Laser en Bloc Resection of bladder tumor
Electrical transurethral resection of bladder tumor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Oct 23, 2016

First Submission Date that Met QC Criteria

Oct 31, 2016

First Posted Date

Nov 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

172Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thulium Laser en Bloc Resection of bladder tumor	Experimental	Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser	Procedure: Thulium Laser en Bloc Resection of bladder tumor
Electrical transurethral resection of bladder tumor	Active Comparator	Electrical transurethral resection of the Non-muscle Invasive Bladder tumor	Procedure: Electrical transurethral resection of bladder tumor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thulium Laser en Bloc Resection of bladder tumor	Procedure		Thulium Laser en Bloc Resection of bladder tumor
Electrical transurethral resection of bladder tumor

Measure	Description	Time Frame
The residual rate of tumor in the second operation of the two surgical methods		2 years

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases