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Prevalence of Gastric Inlet Patches of the Cervical Esophagus.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01056003
Enrollment
4000
Registered
2010-01-26
Start date
2010-06-30
Completion date
2011-06-30
Last updated
2010-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

gastric inlet patch, prevalence, globus sensations

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?

Interventions

OTHEREndoscopy

observational endoscopy in all patients an EGD is planned anyway

Sponsors

Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München
CollaboratorUNKNOWN
Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München
CollaboratorUNKNOWN
Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm
CollaboratorUNKNOWN
Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
CollaboratorUNKNOWN
Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No

Exclusion criteria

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

Countries

Germany

Contacts

Primary ContactMonther Bajbouj, MD
monther.bajbouj@lrz.tum.de+49-89-41400
Backup ContactAlexander Meining, Professor
alexander.meining@lrz.tum.de+49-89-41400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026