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Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01880892
Recruitment Status : Recruiting
First Posted : June 19, 2013
Last Update Posted : October 16, 2019
Information provided by (Responsible Party):
David G. Lott, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date October 16, 2019
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01880892 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2013)
  • Reflux symptom index (RSI) score [ Time Frame: 3 months postoperatively ]
  • Mayo Dysphagia Questionnaire Score [ Time Frame: 3 months postoperatively ]
  • Reflux finding score [ Time Frame: 3 months postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy
Official Title  ICMJE Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy
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?
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Laryngopharyngeal Reflux
  • Zenker's Diverticulum
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
  • Device: Restech's Dx-pH Probe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2013)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01880892
Other Study ID Numbers  ICMJE 12-010052
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David G. Lott, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Lott, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP