Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/12/2018
Start Date:June 2013
End Date:April 2019

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In patients with gastroesophageal reflux and/or laryngopharyngeal reflux with cricopharyngeal
hypertrophy or Zenker's diverticulum, does cricopharyngeal myotomy increase the amount of
laryngopharyngeal reflux?

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.

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
We found this trial at
1
site
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: David Lott, MD
Phone: 480-342-2983
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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