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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439439

Enrollment

Registered

2007-02-23

Start date

2006-10-31

Completion date

2008-05-31

Last updated

2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders, Globus

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.

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.

Interventions

RADIATIONBeamer Ablation (Argon Plasma Coagulation)

APC-Beamerablation of heterotopic gastric mucosa

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026