Clinical trial NCT01056003: Prevalence of Gastric Inlet Patches of the Cervical Esophagus.
Official title: Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations
Keywords: gastric inlet patch
prevalence
globus sensations
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München
name: Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München
name: Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm
name: Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
First posted: 2010-01-26
Enrollment: 4000
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD

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?


Eligibility criteria: Exclusion Criteria:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Technical University Munich
name: Monther Bajbouj, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
name: Sybille Koletzko, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München
name: Slim Saadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University Munich
name: Susanne Liptay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ulm
name: Carsten Posovsky
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.