CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

CDx Diagnostics

Status: Withdrawn

Conditions: Laryngeal Tumor; Laryngeal Disease; Laryngopharyngeal Reflux

Treatments: Device: Endo CDx Brush biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03214835

CDx Laryngeal and LPR Study

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Brush biopsy for laryngeal lesion

Experimental group

Description:

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

Treatment:

Device: Endo CDx Brush biopsy

Brush biopsy for LPR

Experimental group

Description:

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

Treatment:

Device: Endo CDx Brush biopsy