Prevalence of Gastric Inlet Patches of the Cervical Esophagus.

Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations.

As known from several observational and retrospective endoscopic studies the prevalence of gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most cases GIPs are found within endoscopy as an incident finding, since in most cases they are harmless and do not cause any symptoms. None the less several data exist where an association between GIPs and globus sensations is discussed. Case reports even refer to bleeding complications and moreover to malignant transformations of GIPs.

As a result of the assumed association of GIPs and globus sensations we performed a pilot trial. Here we included 10 patients with globus and GIPs and were able to demonstrate a significant symptom relief after ablation of the GIP (Meining et al, Endoscopy 2006). To exclude a potential placebo-effect we concluded a multicenter and sham controlled trial where we imposingly were able to prove the symptom relief after ablation of the GIPs (Bajbouj et al, Gastroenterology 2009).

All patients, who are scheduled for esophagogastroduodenoscopy (EGD) in any of the above mentioned endoscopical departments are routinely standardized asked whether they have any hints suggestive for globus sensations (modified globus-questionnaire from Deary et al., J Psychosom Res 1995). Concurrently it is noted, whether the patients have endoscopical detected GIP. All GIPs are biopsied and examined in one institute. Together with anamnestic data (age, gender) a talley sheet gives a survey of all relevant information to prove or disprove following hypotheses.

Study hypotheses:

1. The presence of GIPs is associated with globus sensations. In other words: Do patients with globus sensations significantly more often have GIPs?
2. GIPs are not congenital, they arise in the course of the time and become symptomatic. In other words: Do GIPs significantly occur in more elderly people?
3. The more increased the GIPs diameter is the more likely globus sensations are present? In other words: Do huge GIPs cause significantly more often symptoms than small ones?
4. The more mucus-producing mucosa is histologically proven the more likely globus sensations are present? In other words: Do we find more cardiac mucosa in patients with symptoms than fundus mucosa?

Study Overview

• Status: Unknown
• Conditions: Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations
• Intervention / Treatment: Other: Endoscopy

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Monther Bajbouj, MD; Phone Number: +49-89-41400; Email: monther.bajbouj@lrz.tum.de
• Study Contact Backup: Name: Alexander Meining, Professor; Phone Number: +49-89-41400; Email: alexander.meining@lrz.tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar
      • Contact: Monther Bajbouj, MD; Phone Number: +49-89-41400; Email: monther.bajbjouj@lrz.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD

Description

Exclusion Criteria:

• emergency EGD
• any condition which contraindicates biopsy sampling
• unavailable informed consent for the GD

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
all patients admitting endoscopy for EGD	Other: Endoscopy; observational endoscopy in all patients an EGD is planned anyway

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München; Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München; Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm; Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
• Investigators: Principal Investigator: Monther Bajbouj, MD, Technical University Munich; Principal Investigator: Sybille Koletzko, Professor, Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München; Principal Investigator: Slim Saadi, MD, Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München; Principal Investigator: Susanne Liptay, MD, Technical University Munich; Principal Investigator: Carsten Posovsky, University Ulm

Publications and helpful links

General Publications

• Bajbouj M, Becker V, Eckel F, Miehlke S, Pech O, Prinz C, Schmid RM, Meining A. Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology. 2009 Aug;137(2):440-4. doi: 10.1053/j.gastro.2009.04.053. Epub 2009 May 4.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ANTICIPATED): June 1, 2011
• Study Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: January 24, 2010
• First Submitted That Met QC Criteria: January 24, 2010
• First Posted (ESTIMATE): January 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 24, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: prevalence; gastric inlet patch; globus sensations
• Additional Relevant MeSH Terms: Mental Disorders; Conversion Disorder; Somatoform Disorders; Globus Sensation
• Other Study ID Numbers: Gips in Kids