An interventional study of Endoscopic fulguration in Bladder Cancer, sponsored by Vall Hebron Insitut Recerca. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by Vall Hebron Insitut Recerca · Not applicable, Interventional, and Treatment
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →This is the only study on the registry with Vall Hebron Insitut Recerca as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery
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
Procedure: Endoscopic fulguration
already included. WE will use Storz monopolar device for fulguration
Also known as: Active surveillance
Progression rate
Number of patients that progress during the follow up
Time frame: two years
Complications rate
Number and grade of complications in both arms. Clavien Dindo Scale will be used
Time frame: two years
recurrence rate
number of recurrences
Time frame: two years
quality of life measured with CAVICAVENMI questionnaire
quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used
Time frame: two years
Plan to share: Yes — codified information (anonymous information)
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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