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| Descriptive Information Fields | |||||
| Brief Title † | ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations | ||||
| Official Title † | ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study | ||||
| Brief Summary | 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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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Globus Deglutition Disorders |
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| Intervention † | Radiation: Beamer Ablation (Argon Plasma Coagulation) | ||||
| MEDLINE PMIDs | 16802267 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 40 | ||||
| Start Date † | October 2006 | ||||
| Completion Date | May 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00439439 | ||||
| Organization ID | 1427/05 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Technische Universität München | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Technische Universität München | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | February 21, 2007 | ||||
| Last Updated Date | May 19, 2008 | ||||
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