ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations - Full Text View

Purpose

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.

Condition	Intervention
Globus Deglutition Disorders	Radiation: Beamer Ablation (Argon Plasma Coagulation)

MedlinePlus related topics:

Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study

Official Title:	ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	October 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Sham Comparator Sham Procedure	Radiation: Beamer Ablation (Argon Plasma Coagulation) APC-Beamerablation of heterotopic gastric mucosa
B: Active Comparator Verum Beamer ablation of heterotopic gastric mucosa	Radiation: Beamer Ablation (Argon Plasma Coagulation) APC-Beamerablation of heterotopic gastric mucosa

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439439

Locations


Germany, Bavaria
	II. Medical Department, Technical University Munich
	Munich, Bavaria, Germany, 81675

Sponsors and Collaborators

Technische Universität München

Investigators


Principal Investigator:	Alexander Meining, MD	II. Medical Department, TU-Munich

More Information

Publications:

Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. 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.

Responsible Party:	Technische Universität München ( II: Medizinische Klinik )
Study ID Numbers:	1427/05
First Received:	February 21, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00439439
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Deglutition Disorders

Otorhinolaryngologic Diseases

Digestive System Diseases

Esophageal disorder

Gastrointestinal Diseases

Esophageal Diseases

Pharyngeal Diseases

ClinicalTrials.gov processed this record on September 08, 2008

Sponsored by:	Technische Universität München
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00439439