Analysis of Biopsies From the Upper Gastrointestinal Tract

NCT ID: NCT01576289

Last Updated: 2012-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-05-31

Brief Summary

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

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.

Conditions

Gastroesophageal Reflux Disease; Gastritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing uppper endoscopy

Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012.

Histological analysis

Intervention Type: OTHER

Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Interventions

Histological analysis

Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• none

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Cord Langner, MD

MD, Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cord Langner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria

Locations

Medical University

Graz, , Austria

Countries

Austria

Other Identifiers

Reflux_Multicenter_1

Identifier Type: -

Identifier Source: org_study_id