跳至主要内容
临床试验/NCT05695846
NCT05695846撤回不适用

Development of Physiology- and Pathophysiology-based Diagnostic Tests and Therapeutics for Patients With Pharyngeal Reflux of Gastric Content

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
90
试验地点
2
主要终点
Endoscopic evidence of supra-esophageal reflux

研究概览

简要总结

After defining the manometric characteristics of UES incompetence associated with documented pharyngeal reflux, we will determine the reproducibility of manometric criteria for UES incompetence in prevention of pharyngeal reflux. We hypothesize that these criteria are comprised of either a single or constellation of manometric abnormalities. After determining the ability of externally applied cricoid cartilage pressure in preventing pharyngeal reflux, we further hypothesize that this approach will eliminate or reduce esophago-pharyngeal reflux by enhancing the UES pressure barrier. We anticipate there will be a close spatial correlation between the site of applied pressure and area of increased pressure within UES high pressure zone. Lastly, we will determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow, testing the hypothesis that these functions will not be impaired.

详细描述

Study subjects: we will study gastroesophageal reflux disease (GERD) patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. Supraesophageal gastroesophageal reflux disease (SE-GERD). The presence of GERD will be verified in their records by result of prior endoscopy or pH monitoring within the past two years. It not, they will undergo transnasal esophagogastroduodenoscopy (T-EGD). If negative, they will undergo pH monitoring off medications to ascertain presence of GERD according to clinically accepted criteria (AGA guidelines (39). We will not enroll patients with functional heartburn (Rome III criteria (40). For Supra-esophageal complications we will use the endoscopic criteria used in clinical Ear, Nose and Throat (ENT) practice and validated symptom severity index questionnaire (developed by Belafsky et al) with the help of our otolaryngologist co-investigator Dr. Joel Blumin.

Study position: studies will be done in supine postures due to vulnerability of the airway in this position.

Instrumentation: all instrumentations will be trans-nasal following application of 2% lidocaine limited to the nasal cavity.

Study technique: concurrent video-pharyngo-laryngoscopy and combined high-resolution manometry and impedance recording along with pH monitoring.

All study participants will give written informed consent followed by filling out a general health questionnaire. Additionally, a Belafsky Index will also be filled out in the same session by the study participant to assess the level of symptoms within the last month associated with supraesophageal reflux.

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

盲法说明

Data analysis staff will be blinded with regard to patient status.

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920).

排除标准

  • Age <20 or >85
  • History or active alcohol or drug abuse
  • History of upper GI and ears, nose, throat and pulmonary diseases that may affect the oropharyngoesophageal axis and stomach
  • History of malignancy and chemo-radiation therapy
  • Unable to give consent
  • Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section).
  • History of allergy to Lidocaine for nasal topical anesthesia.

结局指标

主要结局

Endoscopic evidence of supra-esophageal reflux

时间窗: Procedure (During simulated reflux perfusion of the esophagus)

Visually confirmed supra-esophageal refluxate seen during video endoscopy and log the number of reflux episodes duing each simulated esophageal reflux infusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reza Shaker, MD

Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology

Medical College of Wisconsin

研究点 (2)

Loading locations...

相似试验

Diagnostic Tests in Supra-Esophageal... | 临床试验