CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

Conditions
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Laryngeal Disease, Laryngeal Tumor, Laryngopharyngeal Reflux

Intervention / Treatment
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* Device: Endo CDx Brush biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or over patients suspected to suffer from LPR Patients with laryngeal/hypopharyngeal lesions. Exclusion Criteria: Patient refusal Patients with anatomical variants which precludes biopsy taking. Patients with allergy to lidocain-based local anesthesia agents.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brush biopsy for laryngeal lesion<br>Brush biopsy of the larynx - in addition to the standard biopsy | Device: Endo CDx Brush biopsy<br>* 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.<br>|
| Experimental: Brush biopsy for LPR<br>Brush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe) | Device: Endo CDx Brush biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of EndoCDx brush | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain | Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Larynx, reflux, LPR, tumor, lesion