perilymphatic fistula (PLF)
Conditions
Interventions
Testing on PLF suspected cases. Compare the clinical characteristics of CTP positive cases and negative cases. Diagnostic accuracy of the test is evaluated by testing on non- PLF cases and definit
Sponsors
Saitama Medical University Faculty of Medicine, Otorhinolaryngology,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PLF suspected cases based on the proposed Japanese PLF diagnostic Criteria 2013 1. Definite cases 1) Visual identification of fistula(s) between the middle and inner ear by microscope or endoscope. 2) Biochemical detection of perilymph specific protein, such as Cochlin-tomoprotein (CTP). 2. Suspected cases Cochlear and/or Vestibular symptoms were observed due to known causes or after preceding events as described below. 1) Trauma such as temporal bone fractures or penetrating middle ear trauma. Middle and inner ear diseases (cholesteatoma, tumor, anomaly, SCCD, etc.) . Middle and/or inner ear surgeries. 2) Barotrauma caused by antecedent events of external origin (e.g., blasting, blow to the head/ear, diving, or flying) 3) Barotrauma caused by antecedent events of internal origin (e.g., blowing nose, sneezing, straining, or carrying heavy objects) 3. Comments 1) Idiopathic cases have been identified by the biochemical test (CTP detection test). 2) Following symptoms and test results may be observed. a. Tinnitus like running water sound. b. Popping sound in the ears. c. Nystagmus and/or vertigo induced by pressure application to the middle ear (Hennebert's phenomenon, fistula sign). d. Imaging study may show fistula or pneumolabyrinth. e. Symptoms may be acute, progressive, fluctuate, or recurrent. Vestibular symptoms may be the chief complaint of patients. Diagnostic accuracy of the test is evaluated by testing on non- PLF cases and definite PLF cases (surgical PLF).
Exclusion criteria
Exclusion criteria: (1) acoustic neurinoma or other CNS disorder causing hearing loss by MRI scan, (2) viral labyrinthitis by clinical symptoms and increase of antibody titer, (3) sensorineural hearing loss occurring after administration of aminoglycosides, loop diuretics or platinum-based drugs, (4) severe systemic illness with a short life expectancy such as malignant tumors, (5) pregnancy or lactation, (6) diagnosis as inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of CTP and concentration. Auditory and vestibular test results, symptoms of the cases. | — |
Countries
Japan,Asia(except Japan),North America,Australia,Europe
Contacts
Public ContactTetsuo Ikezono
Saitama Medical University Faculty of Medicine, Otorhinolaryngology
Outcome results
None listed