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Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy

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ClinicalTrials.gov Identifier: NCT01880892
Recruitment Status : Recruiting
First Posted : June 19, 2013
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
David G. Lott, M.D., Mayo Clinic

Brief Summary:
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?

Condition or disease Intervention/treatment Phase
Laryngopharyngeal Reflux Zenker's Diverticulum Procedure: Cricopharyngeal myotomy Device: Restech's Dx-pH Probe Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy
Study Start Date : June 2013
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Post cricopharyngeal myotomy
There is only one arm to the study. This is patients who have undergone cricopharyngeal myotomy for Zenker's diverticulum. Their levels of laryngopharyngeal reflux will be measured using the Restech Dx-pH device.
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.

Device: Restech's Dx-pH Probe
This is not an intervention, but a newer device that measure the pH of the nasopharynx and detects laryngopharyngeal reflux. We will perform 24 hour tests with this device to see if there is an increase in laryngopharyngeal reflux follow cricopharyngeal myotomy.




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

Secondary Outcome Measures :
  1. Reflux symptom index (RSI) score [ Time Frame: 3 months postoperatively ]
  2. Mayo Dysphagia Questionnaire Score [ Time Frame: 3 months postoperatively ]
  3. Reflux finding score [ Time Frame: 3 months postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880892


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Jaime L Matthaeus, PA-C    480-342-2983    matthaeus.jaime@mayo.edu   
Principal Investigator: David Lott, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David Lott, MD Mayo Clinic

Additional Information:
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Responsible Party: David G. Lott, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01880892     History of Changes
Other Study ID Numbers: 12-010052
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Diverticulum
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Zenker Diverticulum
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Pathological Conditions, Anatomical
Diverticulum, Esophageal