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Laryngopharyngeal RefluxNCT01880892

Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy

A study testing Cricopharyngeal myotomy and PH probe Testing in people with Laryngopharyngeal Reflux and Zenker's Diverticulum, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cricopharyngeal myotomy and PH probe Testing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jun 2013to 2 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cricopharyngeal myotomy, PH probe Testing
Medical subject headings
Laryngopharyngeal Reflux, Zenker Diverticulum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cricopharyngeal myotomyProcedure or surgery

    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.

  • PH probe TestingDiagnostic test

    24 hour PH probe testing, which will measure acid reflux following cricopharyngeal myotomy.

Study groups in NCT01880892
Study groupRoleWhat they receive
Post cricopharyngeal myotomyExperimentalSubjects 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.
Receives: Procedure: Cricopharyngeal myotomy; Diagnostic Test: PH probe Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of LPR measured by: number of pH drops >3 standard deviations from baseline and the pharyngeal composite pH score.

    Measured: 3 months postoperatively

Secondary outcomes (3)
  1. Reflux symptom index (RSI) score

    Measured: 3 months postoperatively

  2. Mayo Dysphagia Questionnaire Score

    Measured: 3 months postoperatively

  3. Reflux finding score

    Measured: 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion2 Jan 2018
  4. Study completion2 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880892
Sponsor's protocol ID
12-010052
Status last verified
Jul 2022
First submitted
14 Jun 2013
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cricopharyngeal myotomy and PH probe Testing in people with Laryngopharyngeal Reflux and Zenker's Diverticulum, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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