Prevalence of Gastric Inlet Patches of the Cervical Esophagus.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Technische Universität München.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München
Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München
Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm
Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01056003
First received: January 24, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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:

  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?

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.

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

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
Study Population

all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD

Criteria

Exclusion Criteria:

  • emergency EGD
  • any condition which contraindicates biopsy sampling
  • unavailable informed consent for the GD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056003

Contacts
Contact: Monther Bajbouj, MD +49-89-41400 monther.bajbouj@lrz.tum.de
Contact: Alexander Meining, Professor +49-89-41400 alexander.meining@lrz.tum.de

Locations
Germany
Klinikum rechts der Isar Not yet recruiting
Munich, Bavaria, Germany, 81675
Contact: Monther Bajbouj, MD    +49-89-41400    monther.bajbjouj@lrz.tum.de   
Sponsors and Collaborators
Technische Universität München
Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München
Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München
Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm
Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
Investigators
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 August 27, 2014