Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors

Not Applicable

• Conditions: Bladder Cancer
• Interventions: Procedure: Endoscopic fulguration

• Registration Number: NCT05148728
• Lead Sponsor: Vall Hebron Insitut Recerca

Brief Summary

Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.

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

Not available

Study Timeline

• Study First Submitted: 2021-11-26
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-07
• Last Update Submitted: 2021-12-07
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Study Start: 2021-12-15
• Primary Completion: 2023-12-15
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
• Accept cystoscopy surveillance
• Main lession less than 10mm
• Less than 7 lesions
• Negative or low grade cytology
• No solid aspect

Exclusion Criteria

• previous High grade bladder cancer tumors
• previous Cis
• previous Upper Urinary Tract tumor
• previous pelvic radiotherapy
• hematuria
• meatal localisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic fulguration	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

Primary Outcome Measures

Name	Time	Method
Progression rate	two years	Number of patients that progress during the follow up
Complications rate	two years	Number and grade of complications in both arms. Clavien Dindo Scale will be used

Secondary Outcome Measures

Name	Time	Method
recurrence rate	two years	number of recurrences
quality of life measured with CAVICAVENMI questionnaire	two years	quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used

Trial Locations

Locations (1)

Fernando Lozano Palacio; 🇪🇸 Barcelona, Spain