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ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations

NCT ID: NCT00439439

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Globus Deglutition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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A

Sham Procedure

Group Type SHAM_COMPARATOR

Beamer Ablation (Argon Plasma Coagulation)

Intervention Type RADIATION

APC-Beamerablation of heterotopic gastric mucosa

B

Verum Beamer ablation of heterotopic gastric mucosa

Group Type ACTIVE_COMPARATOR

Beamer Ablation (Argon Plasma Coagulation)

Intervention Type RADIATION

APC-Beamerablation of heterotopic gastric mucosa

Interventions

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Beamer Ablation (Argon Plasma Coagulation)

APC-Beamerablation of heterotopic gastric mucosa

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Technische Universität München

Principal Investigators

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Alexander Meining, MD

Role: PRINCIPAL_INVESTIGATOR

II. Medical Department, TU-Munich

Locations

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II. Medical Department, Technical University Munich

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 16802267 (View on PubMed)

Other Identifiers

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1427/05

Identifier Type: -

Identifier Source: org_study_id