Prevalence of Gastric Inlet Patches of the Cervical Esophagus.

NCT ID: NCT01056003

Last Updated: 2010-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-06-30

Brief Summary

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?

Conditions

Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

all patients admitting endoscopy for EGD

Endoscopy

Intervention Type: OTHER

observational endoscopy in all patients an EGD is planned anyway

Interventions

Endoscopy

observational endoscopy in all patients an EGD is planned anyway

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

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

• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München

UNKNOWN

Sponsor Role: collaborator

Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München

UNKNOWN

Sponsor Role: collaborator

Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm

UNKNOWN

Sponsor Role: collaborator

Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München

UNKNOWN

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Klinikum rechts der Isar, Technische Universitaet Munich

Principal Investigators

Monther Bajbouj, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University Munich

Sybille Koletzko, Professor

Role: PRINCIPAL_INVESTIGATOR

Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München

Slim Saadi, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München

Susanne Liptay, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University Munich

Carsten Posovsky

Role: PRINCIPAL_INVESTIGATOR

University Ulm

Locations

Klinikum rechts der Isar

Munich, Bavaria, Germany

Countries

Germany

Central Contacts

Monther Bajbouj, MD

Role: CONTACT

monther.bajbouj@lrz.tum.de

+49-89-41400

Alexander Meining, Professor

Role: CONTACT

alexander.meining@lrz.tum.de

+49-89-41400

Facility Contacts

Monther Bajbouj, MD

Role: primary

monther.bajbjouj@lrz.tum.de

+49-89-41400

References

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.

Reference Type: RESULT

PMID: 19410576 (View on PubMed)

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: RESULT

PMID: 16802267 (View on PubMed)

Other Identifiers

Gips in Kids

Identifier Type: -

Identifier Source: org_study_id