Analysis of Biopsies From the Upper Gastrointestinal Tract

Completed

• Conditions: Gastritis; Gastroesophageal Reflux Disease
• Interventions: Other: Histological analysis

• Registration Number: NCT01576289
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• none

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing uppper endoscopy	Histological analysis	Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012.

Trial Locations

Locations (1)

Medical University; 🇦🇹 Graz, Austria