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

October 31, 2016 updated by: Liu Haitao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

October 23, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (ESTIMATE)

November 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiCTR-INR-16009513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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