Gastroesophageal Reflux Disease Clinical Trial
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)
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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