ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

Technical University of Munich

Status: Completed

Conditions: Globus; Deglutition Disorders

Treatments: Radiation: Beamer Ablation (Argon Plasma Coagulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT00439439

1427/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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40 participants in 2 patient groups

A

Sham Comparator group

Description:

Sham Procedure

Treatment:

Radiation: Beamer Ablation (Argon Plasma Coagulation)

B

Active Comparator group

Description:

Verum Beamer ablation of heterotopic gastric mucosa

Treatment:

Radiation: Beamer Ablation (Argon Plasma Coagulation)