ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

T

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

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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