- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110483
Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive Bladder Cancer
Safety and Short-term Oncological Outcomes of Thulium Fiber Laser En-bloc Resection of Non-muscle-invasive Bladder Cancer
Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection.
Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Moscow, Russian Federation, 119991
- Clinic of Urology, Sechenov University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Primary Ta or T1 bladder cancer (NMIBC)
Exclusion Criteria:
• Pure carcinoma in situ
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: TURBT
A step-by-step resection of a tumor.
Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible.
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After cystoscopy and determining tumor topography, a step-by-step resection of a tumor is done.
Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible.
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EXPERIMENTAL: Tm-fiber ERBT
A circumferential incision around the tumor is made in the visually intact bladder mucosa.
After that, the incision is continued deeper into the muscular layer.
Than the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers.
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After cystoscopy and determining tumor topography, a circumferential incision around the tumor is made in the visually intact bladder mucosa (approximately 10 mm from the edges of the tumor).
It allows for accurate morphological evaluation of the surgical margin.
After that, the incision is continued deeper into the muscular layer.
Having identified the layer, the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers.
Making incisions in the muscular layer requires precision, a full bladder and adequate guidance with visualization techniques.
Traction may be employed with the help of the tip of the resectoscope or working element.
After complete tumor resection, local hemostasis was performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence-free survival rate
Time Frame: 3 month
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Absence of cancer at the site of previous resection on histological examination after re-biopsy
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3 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detrusor presence in the specimen
Time Frame: 1 day after the surgery
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The presence of muscle fibers in specimens on histological investigation
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1 day after the surgery
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Complications
Time Frame: up to 1 year
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Rate of postoperative complications, their severity according Clavien-Dindo score
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up to 1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sechenov-ERBT-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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