ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00439439
First received: February 21, 2007
Last updated: May 19, 2008
Last verified: May 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 21, 2007
Last Updated: May 19, 2008
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 19, 2014