ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

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.

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Key information

Conditions

Globus Conversion Disorder Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Globus Sensation Mental Disorders Otorhinolaryngologic Diseases Pharyngeal Diseases Somatoform Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

II. Medical Department, Technical University Munich

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beamer Ablation (Argon Plasma Coagulation)

Radiation

APC-Beamerablation of heterotopic gastric mucosa

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Feb 23, 2007
Registry last updated: May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed