outer ear cholesteatoma, middle ear cholesteatoma
Conditions
Interventions
outer ear cholesteatoma 5-FU : 8 ears Placebo(hydrophilic cream) : 8 ears Dose:The 5-FU ointment or placebo medicine of the piece of rice size(200mg) is applied to the cholesteatoma with a cott
Sponsors
Nagasaki University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.outer ear cholesteatoma or middle ear cholesteatoma equivalent to a mild to moderate leision 2.patient 20 years or older at the time of the agreement acquisition 3.outpatient 4.The patients from whom informed consent from their free will was obtained after a sufficient explanation.
Exclusion criteria
Exclusion criteria: 1.advanced cholesteatoma 2.middle ear cholesteatoma having eardrum perforation or an inner ear fistula 3.patients having a history of the drug allergies 4.pregnant patient and those who have possibility of pregnancy, or breast-feeding patient 5.the patient whom a principal investigator judged to be inappropriate as a study subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of the area (mm2) of the cholesteatoma in the slice that the cholesteatoma shadow was depicted at a maximum area before treatment in temporal bone axial CT | — |
Secondary
| Measure | Time frame |
|---|---|
| Size and/or visibility of cholesteatoma mass through transmeatal endoscopy | — |
Countries
Japan
Contacts
Public ContactKensuke Hatachi
Nagasaki University hospital Department of Otolaryngology-Head and Neck Surgery
Outcome results
None listed