Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations Clinical Trial
Official title:
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?
| Status | Not yet recruiting |
| Enrollment | 4000 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 90 Years |
| Eligibility |
Exclusion Criteria: - emergency EGD - any condition which contraindicates biopsy sampling - unavailable informed consent for the GD |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum rechts der Isar | Munich | Bavaria |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität München | Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München, Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München, Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München, Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm |
Germany,
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.gast — View Citation
Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Höfler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2 — View Citation