Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors
NCT ID: NCT05148728
Last Updated: 2021-12-08
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
120 participants
INTERVENTIONAL
2021-12-15
2024-03-15
Brief Summary
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Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.
This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.
This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active surveillance
After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery
No interventions assigned to this group
endoscopic fulguration
After a recurrence in patient with previous low grade bladder cancer tumor, fulguration under local anesthesia and sedation will be performed using a flexible cystoscope and a monopolar electrode
Endoscopic fulguration
already included. WE will use Storz monopolar device for fulguration
Interventions
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Endoscopic fulguration
already included. WE will use Storz monopolar device for fulguration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Accept cystoscopy surveillance
* Main lession less than 10mm
* Less than 7 lesions
* Negative or low grade cytology
* No solid aspect
Exclusion Criteria
* previous Cis
* previous Upper Urinary Tract tumor
* previous pelvic radiotherapy
* hematuria
* meatal localisation
18 Years
ALL
No
Sponsors
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Vall Hebron Insitut Recerca
NETWORK
Responsible Party
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Locations
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Fernando Lozano Palacio
Barcelona, , Spain
Countries
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Facility Contacts
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Fernando FL Lozano, MD
Role: primary
Other Identifiers
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PR(AG)401/2021
Identifier Type: -
Identifier Source: org_study_id