Laryngopharyngeal Reflux Clinical Trial
Official title:
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.
First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR
or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be
performed by a laryngologist that will complete the RFS score.
Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush
biopsy in order to determine whether the lesions are malignant or benign. The pathologic
diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology
results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma
in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for
definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear.
Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before
removal of the lesion a CDx brush smear will be collected.
All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush
biopsy.All relevant demographic and clinical data will be retrieved for analysis.
CDx biopsies will be an addition to the routine management of the patients in the diagnosis
and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.
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