Non-muscle Invasive Bladder Cancer Clinical Trial
Official title:
Comparison of the Pathological Stage and Clinical Outcome of en Bloc Transurethral Resection by HybridKnife or Laser Versus Conventional Transurethral Resection for NMIBC: a Prospective, Single Centre, Randomized Study
Verified date | July 2017 |
Source | Tongji Hospital |
Contact | Jia Hu, MD PhD |
Phone | +86 13986089626 |
jiahutjm[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The traditional method of choice for intravesical resection of bladder tumors is conventional transurethral resection of bladder tumor (cTURBT). However, there has long been an ambition to overcome its biggest limitation, tumor fragmentation. Possible consequences include cell seeding and poor specimen quality, including missing detrusor muscle, thermal tissue damage, and tissue fragmentation. En bloc resection of bladder tumor (ERBT) represents an alternative technique for resection of bladder tumors. There is no doubt that ERBT has huge potential. ERBT provides specimens of high quality that are easy for pathologists to read. In theory, this may sustainably change the view on secondary resection, lead to faster decisions on subsequent treatments, and influence patient prognosis. Thus, there is an urgent need to compare ERBT with cTURBT in a thoroughly planned trial.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Pathological or histological diagnosis by cystoscopy of primary non-muscle invasive bladder urothelial carcinoma (Ta, T1); 2. Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis; 3. Diameter of tumor 1-3cm 4. Number of lesions=3 (The position of small lesions relatively concentrated as one place) 5. Patients who agree to ERBT or cTURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation Exclusion Criteria: 1. Tis or non-transitional epithelial tumors 2. Pathological or imaging examinations showed the bladder muscle has not been affected 3. There has surgery contraindications, such as bladder fibrosis 4. Diameter of tumor >3cm or <1cm 5. Number of lesions>3 6. Anteriorly located tumor 7. Received chemotherapy or BCG perfusion therapy in the nearly 3 months 8. Poor performance status is difficult to tolerate surgery 9. The patient refused to sign a consent form |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The pathological staging assessment | The pathological staging assessment for ERBT or cTURBT procedure | one week | |
Primary | The recurrence rate assessment at resection sites | The recurrence rate assessment at resection sites for ERBT or cTURBT procedure | two year | |
Secondary | periprocedure complications | Modified Clavien scale will be used for reporting and comparison of periprocedure complications(obturator nerve reflection;bladder perforation) | 2 days |
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