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ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439439
First Posted: February 23, 2007
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität München
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
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
Sham Comparator: A
Sham Procedure
Radiation: Beamer Ablation (Argon Plasma Coagulation)
APC-Beamerablation of heterotopic gastric mucosa
Active Comparator: B
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439439


Locations
Germany
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:
Responsible Party: II: Medizinische Klinik, Technische Universität München
ClinicalTrials.gov Identifier: NCT00439439     History of Changes
Other Study ID Numbers: 1427/05
First Submitted: February 21, 2007
First Posted: February 23, 2007
Last Update Posted: May 20, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases