Trials / Completed
CompletedNCT00439439
ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Technical University of Munich · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Beamer Ablation (Argon Plasma Coagulation) | APC-Beamerablation of heterotopic gastric mucosa |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2007-02-23
- Last updated
- 2008-05-20
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00439439. Inclusion in this directory is not an endorsement.