Non muscle invasive bladder cancer
Conditions
Interventions
Two to two and half hours prior endoscopy 1.5g 5-aminolevulinic acid(5-ALA)(unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 8.4% sodium hydrogen carbonate(NaHCO3) solution
Sponsors
Department of urology and Andrology, Kansai Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patient who has primary and recurrent superficial bladder cancer indicated for transurethral biopsy of bladder mocosa (TU-biopsy) and/or transurethral resection of bladder tumor (TURBT)
Exclusion criteria
Exclusion criteria: patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety:The occurrence frequency and degree of adverse event were investigated through the procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy : The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results. The diagnostic capability of photodynamic diagnosis (PDD) using fluorescence (blue light) endoscopy was compared to that in conventional diagnostic method using white light endoscopy. | — |
Countries
Japan
Contacts
Public ContactHidekazu Inui
Kansai Medical University Department of urology and Andrology
Outcome results
None listed