Back to resultsACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
Primary Purpose
Globus, Deglutition Disorders
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Beamer Ablation (Argon Plasma Coagulation)
Sponsored by
About this trial
This is an interventional treatment trial for Globus
Eligibility 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
Sites / Locations
- II. Medical Department, Technical University Munich
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
A
B
Arm Description
Sham Procedure
Verum Beamer ablation of heterotopic gastric mucosa
Outcomes
Primary Outcome Measures
outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months
Secondary Outcome Measures
Full Information
NCT ID
NCT00439439
First Posted
February 21, 2007
Last Updated
May 19, 2008
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00439439
Brief Title
ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
Official Title
ACHAT-STUDY: Argon-Beamer-Ablation of Cervical Heterotopic Gastral Mucosa, an Alternative Treatment of Chronic Globus Sensations - "Sham-Controlled" Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Technical University of Munich
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Globus, Deglutition Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Sham Comparator
Arm Description
Sham Procedure
Arm Title
B
Arm Type
Active Comparator
Arm Description
Verum Beamer ablation of heterotopic gastric mucosa
Intervention Type
Radiation
Intervention Name(s)
Beamer Ablation (Argon Plasma Coagulation)
Intervention Description
APC-Beamerablation of heterotopic gastric mucosa
Primary Outcome Measure Information:
Title
outcome verified by a questionnaire (I.J. Deary et al) before therapy and follow up after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Meining, MD
Organizational Affiliation
II. Medical Department, TU-Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
II. Medical Department, Technical University Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16802267
Citation
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. doi: 10.1055/s-2006-925362.
Results Reference
background
Learn more about this trial
ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
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