Prevalence of Gastric Inlet Patches of the Cervical Esophagus.
Recruitment status was Not yet recruiting
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Purpose
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:
- The presence of GIPs is associated with globus sensations. In other words: Do patients with globus sensations significantly more often have GIPs?
- 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?
- 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?
- 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?
| Condition | Intervention |
|---|---|
|
Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations |
Other: Endoscopy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations. |
| Estimated Enrollment: | 4000 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| all patients admitting endoscopy for EGD |
Other: Endoscopy
observational endoscopy in all patients an EGD is planned anyway
|
Eligibility| Ages Eligible for Study: | up to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD
Exclusion Criteria:
- emergency EGD
- any condition which contraindicates biopsy sampling
- unavailable informed consent for the GD
Contacts and Locations| Contact: Monther Bajbouj, MD | +49-89-41400 | monther.bajbouj@lrz.tum.de |
| Contact: Alexander Meining, Professor | +49-89-41400 | alexander.meining@lrz.tum.de |
| Germany | |
| Klinikum rechts der Isar | Not yet recruiting |
| Munich, Bavaria, Germany, 81675 | |
| Contact: Monther Bajbouj, MD +49-89-41400 monther.bajbjouj@lrz.tum.de | |
| 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 |
More Information
Publications:
| Responsible Party: | Monther Bajbouj, MD, Klinikum rechts der Isar, Technische Universitaet Munich |
| ClinicalTrials.gov Identifier: | NCT01056003 History of Changes |
| Other Study ID Numbers: | Gips in Kids |
| Study First Received: | January 24, 2010 |
| Last Updated: | January 24, 2010 |
| Health Authority: | Germany: Technical University of Munich |
Keywords provided by Technische Universität München:
|
gastric inlet patch prevalence globus sensations |
ClinicalTrials.gov processed this record on May 16, 2013