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

Vall Hebron Insitut Recerca

Status: Unknown

Conditions: Bladder Cancer

Treatments: Procedure: Endoscopic fulguration

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05148728

PR(AG)401/2021

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Active surveillance

No Intervention group

Description:

After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery

endoscopic fulguration

Active Comparator group

Description:

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

Treatment:

Procedure: Endoscopic fulguration