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临床试验/NCT00439439
NCT00439439已完成不适用

ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months

研究概览

简要总结

Globus sensations are associated with gastroesophageal reflux disease as well as the presence of a gastric inlet patch. No controlled trial exists on whether ablation of the cervical heterotopic mucosa may lead to improvement of chronic globus sensations. The aim of this sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic gastric inlet patches of the esophagus improves patients' chronic globus sensations.

详细描述

Some data suggest that ablation of gastric inlet patches by argon beamer therapy might lead to alleviation of chronic globus sensation or sore throat. Acid reflux or its treatment is unlikely to influence these results (Meining et al. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70). Within the present study we will perform a randomized, sham-controlled and blinded trial, where patients with heterotopic gastric mucosa (HGM) of the cervical esophagus and globus sensations (a chronic or intermittent lump in the throat for at least 3 months) are going to be randomized after histological verification of HGM in the study center (Technical University Clinic Munich). Either a beamer ablation of HGM or a sham-therapy will be performed after patients complete a validated questionnaire. Patients are blinded for 3 months, then after completing another questionnaire endoscopy is repeated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Globus sensations and histologically verified heterotopic gastric mucosa of the cervical esophagus

排除标准

  • Malignancy in the ear, nose, and throat (ENT)-field
  • Scleroderma
  • Mental disability affecting a patient's ability to sign an informed consent document

结局指标

主要结局

outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other

研究点 (2)

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