跳至主要内容
临床试验/NCT01880892
NCT01880892已完成不适用

Laryngopharyngeal Reflux Before and After Cricopharyngeal Myotomy

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
10
试验地点
2
主要终点
Presence of LPR measured by: number of pH drops >3 standard deviations from baseline and the pharyngeal composite pH score.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • pregnant women
  • prisoners
  • adults lacking capacity to consent

结局指标

主要结局

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

时间窗: 3 months postoperatively

次要结局

  • Reflux symptom index (RSI) score(3 months postoperatively)
  • Reflux finding score(3 months postoperatively)
  • Mayo Dysphagia Questionnaire Score(3 months postoperatively)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

David G. Lott, M.D.

PI

Mayo Clinic

研究点 (2)

Loading locations...

相似试验