Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 5:37 AM
Study NCT ID:
NCT01056003
Status:
UNKNOWN
Last Update Posted:
2010-01-26
First Post:
2010-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Gastric Inlet Patches of the Cervical Esophagus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079564', 'term': 'Globus Sensation'}], 'ancestors': [{'id': 'D003291', 'term': 'Conversion Disorder'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-24', 'studyFirstSubmitDate': '2010-01-24', 'studyFirstSubmitQcDate': '2010-01-24', 'lastUpdatePostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric inlet patch', 'prevalence', 'globus sensations'], 'conditions': ['Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations']}, 'referencesModule': {'references': [{'pmid': '19410576', 'type': 'RESULT', '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.'}, {'pmid': '16802267', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAs 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).\n\nAll 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.\n\nStudy hypotheses:\n\n1. The presence of GIPs is associated with globus sensations. In other words: Do patients with globus sensations significantly more often have GIPs?\n2. 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?\n3. 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?\n4. 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?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* emergency EGD\n* any condition which contraindicates biopsy sampling\n* unavailable informed consent for the GD'}, 'identificationModule': {'nctId': 'NCT01056003', 'briefTitle': 'Prevalence of Gastric Inlet Patches of the Cervical Esophagus.', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations.', 'orgStudyIdInfo': {'id': 'Gips in Kids'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'all patients admitting endoscopy for EGD', 'interventionNames': ['Other: Endoscopy']}], 'interventions': [{'name': 'Endoscopy', 'type': 'OTHER', 'description': 'observational endoscopy in all patients an EGD is planned anyway', 'armGroupLabels': ['all patients admitting endoscopy for EGD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'contacts': [{'name': 'Monther Bajbouj, MD', 'role': 'CONTACT', 'email': 'monther.bajbjouj@lrz.tum.de', 'phone': '+49-89-41400'}], 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Monther Bajbouj, MD', 'role': 'CONTACT', 'email': 'monther.bajbouj@lrz.tum.de', 'phone': '+49-89-41400'}, {'name': 'Alexander Meining, Professor', 'role': 'CONTACT', 'email': 'alexander.meining@lrz.tum.de', 'phone': '+49-89-41400'}], 'overallOfficials': [{'name': 'Monther Bajbouj, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University Munich'}, {'name': 'Sybille Koletzko, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München'}, {'name': 'Slim Saadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München'}, {'name': 'Susanne Liptay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University Munich'}, {'name': 'Carsten Posovsky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München', 'class': 'UNKNOWN'}, {'name': 'Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München', 'class': 'UNKNOWN'}, {'name': 'Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm', 'class': 'UNKNOWN'}, {'name': 'Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Monther Bajbouj, MD', 'oldOrganization': 'Klinikum rechts der Isar, Technische Universitaet Munich'}}}}