Analysis of Biopsies From the Upper Gastrointestinal Tract

Gastroesophageal Reflux Disease Clinical Trial

— histoGERD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576289
• Other study ID #: Reflux_Multicenter_1
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: July 23, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastritis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• Histological analysis
Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Locations

Country	Name	City	State
Austria	Medical University	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria,