Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy

The purpose of this study is to see if people with reflux with a Zenker's diverticulum have increased reflux into the throat following a cricopharyngeal myotomy.

Study Overview

• Status: Completed
• Conditions: Laryngopharyngeal Reflux; Zenker's Diverticulum
• Intervention / Treatment: Procedure: Cricopharyngeal myotomy; Diagnostic test: PH probe Testing

Detailed Description

Gastroesophageal reflux is considered to be a common cause of cricopharyngeal dysfunction and Zenker's diverticulum. In patients with severe symptoms of dysphagia, we perform a cricopharyngeal myotomy to release the tension at the upper esophageal sphincter. There has been some speculation that if the upper esophageal sphincter is severed, there could be an increase in reflux into the pharyngeal and laryngeal structures. The current gold standard for measuring laryngopharyngeal reflux (LPR) is 24 hour monitoring with a dual-electrode pH catheter. A newer device specifically measures LPR by sitting in the nasopharynx. The probe has been verified as accurate by several studies, with some postulating that since its recording intervals are closer together, it may be more accurate for measuring LPR. We aim to measure LPR with the new pH probe in patients with gastroesophageal reflux before and after cricopharyngeal myotomy to see if LPR becomes present or worsens after surgery.

All patients presenting with cricopharyngeal dysfunction or Zenker's diverticulum with a diagnosis or symptoms of gastroesophageal reflux or laryngopharyngeal reflux will be asked to participate in the study. If they meet the inclusion criteria, agree to participate, and wish to undergo surgery for their dysphagia, a baseline 24 hr laryngopharyngeal reflux study will be obtained using the Restech probe. Additionally, baseline dysphagia and reflux questionnaires will be obtained and an exam with flexible nasopharyngoscopy will be done. This exam is considered part of a standard exam for this condition and would be performed even if patients were not part of the research study. The surgical procedure will treat their dysphagia no differently than if they were not participating in the study. The patient will have their standard postoperative visit at 4 weeks, where their reflux and dysphagia symptoms will be assessed with questionnaires and a reflux finding score will be calculated via nasopharyngoscopy. At 3 months, an additional 24 laryngopharyngeal reflux study will be conducted with the Restech probe, and the patient will be seen in clinic for their final postoperative visit shortly thereafter. The questionnaires and the flexible nasopharyngoscopy for a reflux finding score will be repeated. The nasopharyngoscopy exam is standard of care for this patient visit. The patient would undergo the same number of nasopharyngoscopies even if they were not part of the study. During the study, if the patient is already on medication for reflux, they will be taken off their medication for 7 days in order to better detect changes in their LPR before and after cricopharyngeal myotomy. This is the standard protocol for patients being tested for LPR by the 24 hr pH probe study with the Restech probe. The patients will serve as their own controls as we are looking for significant increases in the amount of laryngopharyngeal reflux after cricopharyngeal myotomy. The data will be maintained in a database until the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• symptoms of gastroesophageal reflux
• presence of Zenker's diverticulum or cricopharyngeal hypertrophy
• undergoing surgery for Zenker's diverticulum or cricopharyngeal hypertrophy with endoscopic laser cricopharyngeal myotomy
• at least 18 years old

Exclusion Criteria:

• pregnant women
• children
• prisoners
• adults lacking capacity to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post cricopharyngeal myotomy; Subjects scheduled to undergo an endoscopic criocopharyngeal myotomy, which is the standard treatment for a Zenker's diverticulum, will have levels of laryngopharyngeal reflux measured after the procedure.	Procedure: Cricopharyngeal myotomy; Endoscopic laser cricopharyngeal myotomy is one of the standard treatments for Zenker's Diverticulum. It takes about 30 minutes and at our institution requires a one night of observation in the hospital.; Diagnostic test: PH probe Testing; 24 hour PH probe testing, which will measure acid reflux following cricopharyngeal myotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of LPR measured by: number of pH drops >3 standard deviations from baseline and the pharyngeal composite pH score.	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Reflux symptom index (RSI) score	3 months postoperatively
Mayo Dysphagia Questionnaire Score	3 months postoperatively
Reflux finding score	3 months postoperatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David Lott, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 2, 2018
• Study Completion (Actual): January 2, 2018

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 16, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Diverticular Diseases; Laryngeal Diseases; Diverticulum, Esophageal; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Diverticulum; Zenker Diverticulum
• Other Study ID Numbers: 12-010052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No