Analysis of Biopsies From the Upper Gastrointestinal Tract (histoGERD)
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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)|
Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.
|Study Start Date:||November 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Patients undergoing uppper endoscopy
Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012.
Other: Histological analysis
Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576289
|Graz, Austria, 8036|
|Principal Investigator:||Cord Langner, MD||Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria|