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Analysis of Biopsies From the Upper Gastrointestinal Tract (histoGERD)

M

Medical University of Graz

Status

Completed

Conditions

Gastritis
Gastroesophageal Reflux Disease

Treatments

Other: Histological analysis

Study type

Observational

Funder types

Other

Identifiers

NCT01576289
Reflux_Multicenter_1

Details and patient eligibility

About

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

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • none

Exclusion criteria

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

Trial design

600 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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