ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Globus, Deglutition Disorders

Intervention / Treatment
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* Radiation: Beamer Ablation (Argon Plasma Coagulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Globus sensations and histologically verified heterotopic gastric mucosa of the cervical esophagus Exclusion Criteria: Malignancy in the ear, nose, and throat (ENT)-field Scleroderma Mental disability affecting a patient's ability to sign an informed consent document

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: A<br>Sham Procedure | Radiation: Beamer Ablation (Argon Plasma Coagulation)<br>* APC-Beamerablation of heterotopic gastric mucosa<br>|
| Active Comparator: B<br>Verum Beamer ablation of heterotopic gastric mucosa | Radiation: Beamer Ablation (Argon Plasma Coagulation)<br>* APC-Beamerablation of heterotopic gastric mucosa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months |  |  |