Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux

NCT00373997 | Completed Phase 4

• 1 other identifier: 060725
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether patients with suspected Laryngopharyngeal reflux have inflammation and ultrastructural injury on their laryngeal biopsies.

Conditions

Larynx Disease; Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Dilation of intracellular spaces at the beginning of the study

  1 day

Interventions

Esophageal and Laryngeal biopsies PROCEDURE

one day procedure

Also known as: esophagogastroduodenoscopy

egd with biopsy PROCEDURE

standard of care procedure with biopsy

Also known as: esophagogastroduodenoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GERD 1. Documented erosive esophagitis (Patients will be newly diagnosed with esophageal erosion at initial visit via esophagogastroduodenoscopy \[EGD\]) 2.Patients with non-erosive esophagitis who have been responsive to PPI
• LPR 1. Diagnosed via Head \& Neck Institute endoscopists (i.e. patients will be newly diagnosed at initial visit via laryngoscopy)
• Controls
• No complaints or history of heartburn, acid regurgitation, atypical chest pain
• Never been seen by GI or ENT for related symptoms
• No prior therapy for GERD
• Have a medical condition other than reflux for which they need to undergo EGD. These conditions can be diarrhea, peptic ulcer disease, malabsorption, anemia, and dysphagia.

You may not qualify if:

• Age \< 18yrs
• Pregnancy
• Patients with contra-indications for EGD
• Use of antacid (PPI, H2RB) within last 30 days
• Use of any/all medications affecting gastrointestinal motility
• Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric resection
• Patients unable to give informed consent
• Patients unable to comply with follow-up
• Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergies to local anesthetic.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410

Nashville, Tennessee, 37232-5280, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases; Gastroesophageal Reflux

Interventions

Endoscopy, Digestive System; Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Michael F Vaezi, MD, PhD, MS epi

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 8, 2006
• Study Start: September 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 1, 2014

Record last verified: 2011-03

Locations

US (1)