Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
NCT ID: NCT04750590
Last Updated: 2021-02-21
Study Results
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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UNKNOWN
NA
180 participants
INTERVENTIONAL
2021-01-11
2022-06-11
Brief Summary
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Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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en bloc resection group
Patients scheduled for laser en bloc tumor resection with subsequent morcellation of exophytic part of the tumor
en bloc resection, morcellation
Laser en bloc resection with subsequent tumor morcellation will be performed. This tissue will be sent for histology in order to estimate the histological subtype and differentiation grade. Next stage laser resection of the tumor basis will be performed with subsequent histology to determine the depth of invasion and the status of surgical margin.
piecemeal resection group
Patients scheduled for piecemeal bladder tumor TUR with subsequent removing of tissue using the instrument loop or Janet's syringe.
piecemeal resection, tissue removal by loop
Tumor piecemeal resection will be performed with electric loop. Then fragments of the tumor will be removed by the loop or Janet's syringe. Fragments from the base of the tumor will be sent separately in order to assess which stage the tumor is at and its surgical margin status.
Interventions
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en bloc resection, morcellation
Laser en bloc resection with subsequent tumor morcellation will be performed. This tissue will be sent for histology in order to estimate the histological subtype and differentiation grade. Next stage laser resection of the tumor basis will be performed with subsequent histology to determine the depth of invasion and the status of surgical margin.
piecemeal resection, tissue removal by loop
Tumor piecemeal resection will be performed with electric loop. Then fragments of the tumor will be removed by the loop or Janet's syringe. Fragments from the base of the tumor will be sent separately in order to assess which stage the tumor is at and its surgical margin status.
Eligibility Criteria
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Inclusion Criteria
2. Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 and lower)
3. Diameter of tumor \>3cm
Exclusion Criteria
2. Multiple (more than 2) bladder tumors
3. Previous cold-cup biopsy or any other surgery for bladder tumor
4. Muscle-invasive bladder cancer on postoperative histological evaluation
5. Other malignant/benign tumors of the bladder (non-urothelial cancer)
18 Years
ALL
No
Sponsors
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I.M. Sechenov First Moscow State Medical University
OTHER
Responsible Party
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Dmitry Enikeev, MD, PhD
Deputy Director for Research
Principal Investigators
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Dmitry Enikeev, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sechenov University
Locations
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Institute for Urology and Reproductive Health, Sechenov University.
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ERBT -MORC20
Identifier Type: -
Identifier Source: org_study_id
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