Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Gastroesophageal Reflux

Laryngeal Diseases

Laryngopharyngeal Reflux

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

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

Rambam Health Care Campus

CDx Diagnostics

Symptoms and General Pathology

Neoplasms

Esophagitis

Heartburn

Barrett Esophagus

Gastroenteritis

Precancerous Conditions

Signs and Symptoms, Digestive

Marcia Canto, MD

A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

This registry is a prospective, multicenter registry of patients undergoing diagnostic evaluation and/or treatment of gastroesophageal reflux disease and associated diseases and complications.

Patients who are eligible will have disease and therapy-specific data collected throughout treatment and long-term (5-year) follow-up.

Electronic data capture via REDCap will be utilized for all sites.

The Johns Hopkins Heartburn Center Registry

Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.

Establish a registry with collected data related to patients undergoing diagnostic evaluation and treatment of GERD and its associated diseases in multiple academic and community settings.

EndoGastric Solutions

Johns Hopkins University

Nervous System Diseases

Mouth and Tooth Diseases

Dysphonia

Hoarseness

Cough

Voice Disorders

Respiration Disorders

Neurologic Manifestations

Signs and Symptoms, Respiratory

Pharyngeal Diseases

Screening for Barrett's Esophagus

Joshua Schindler, MD

The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract.

It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE.

This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved.

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
The Johns Hopkins Heartburn Center Registry	NCT03853772	Gastroesophagea... Barrett Esophag... Laryngopharynge... Esophagitis		18 Years -	Johns Hopkins University
The Johns Hopkins Heartburn Center Registry	NCT03853772	Gastroesophagea... Barrett Esophag... Laryngopharynge... Esophagitis		18 Years -	Johns Hopkins University
Screening for Barrett's Esophagus in Otolaryngology Patients	NCT00695227	Extraesophageal... Cough Throat Clearing Hoarseness Difficulty Swal...	Screening for B...	18 Years - 90 Years	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Spots Global Cancer Trial Database for laryngopharyngeal reflux