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Analysis of Biopsies From the Upper Gastrointestinal Tract (histoGERD)

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ClinicalTrials.gov Identifier: NCT01576289
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : July 24, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Gastritis Other: Histological analysis

Detailed Description:

Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history.

The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology.

Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.


Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)
Study Start Date : November 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy GERD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients undergoing uppper endoscopy
Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012.
Other: Histological analysis
Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination


Outcome Measures

Biospecimen Retention:   Samples With DNA
Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who routinely undergo upper endoscopy (for different, not selected reasons)
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576289


Locations
Austria
Medical University
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Cord Langner, MD Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria
More Information

Responsible Party: Cord Langner, MD, MD, Senior Scientist, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01576289     History of Changes
Other Study ID Numbers: Reflux_Multicenter_1
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Cord Langner, MD, Medical University of Graz:
Esophagus
Gastroesophageal reflux
Reflux esophagitis
Barrett's esophagus
Stomach
Intestinal metaplasia stomach
Helicobacter pylori infection
Proton pump inhibitor
Duodenum
Duodenal bulb
Celiac disease diagnosis

Additional relevant MeSH terms:
Gastroesophageal Reflux
Gastritis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Stomach Diseases