Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01576289
Acronym
histoGERD
Enrollment
600
Registered
2012-04-12
Start date
2011-11-30
Completion date
2012-05-31
Last updated
2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastritis, Gastroesophageal Reflux Disease

Keywords

Esophagus, Gastroesophageal reflux, Reflux esophagitis, Barrett's esophagus, Stomach, Intestinal metaplasia stomach, Helicobacter pylori infection, Proton pump inhibitor, Duodenum, Duodenal bulb, Celiac disease diagnosis

Brief 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.

Interventions

Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* none

Exclusion criteria

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026