NCT01576289

Analysis of Biopsies From the Upper Gastrointestinal Tract

Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Histological analysis	Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-04-12
• Last updated: 2012-07-24

Locations

1 site across 1 country: Austria