Analysis of Biopsies From the Upper Gastrointestinal Tract (histoGERD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cord Langner, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01576289
First received: April 11, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.


Condition Intervention
Gastroesophageal Reflux Disease
Gastritis
Other: Histological analysis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

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.


Estimated Enrollment: 600
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
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:

  • none

Exclusion Criteria:

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

No publications provided

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
Study First Received: April 11, 2012
Last Updated: July 23, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by 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:
Gastritis
Gastroesophageal Reflux
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014