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Brush biopsy of the larynx - in addition to the standard biopsy

Brush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe)

In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.

Endo CDx Brush biopsy

Jacob Cohen, MD

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.

CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Efficacy of EndoCDx brush biopsy as a diagnostic tool for laryngeal lesions compared to cup forceps biopsy and a diagnostic tool for LPR compared to double probe PH monitoring

Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	NCT03214835	Laryngeal Disea... Laryngeal Tumor Laryngopharynge...	Endo CDx Brush ...	18 Years -	CDx Diagnostics
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	NCT03214835	Laryngeal Disea... Laryngeal Tumor Laryngopharynge...	Endo CDx Brush ...	18 Years -	CDx Diagnostics
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	NCT03214835	Laryngeal Disea... Laryngeal Tumor Laryngopharynge...	Endo CDx Brush ...	18 Years -	CDx Diagnostics

Spots Global Cancer Trial Database for endo cdx brush biopsy