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| ID | Type | Description | Link |
|---|---|---|---|
| 17213538 | Registry Identifier | Endoscopic screening of asymptomatic patients for H. pylori, IM, and Barrett's mucosa during Colonoscopy |
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The goal of this observational study is to learn how common Helicobacter pylori (H. pylori) infection is in adults without stomach or upper gastrointestinal symptoms who are having a preventive screening colonoscopy.
Endoscopic screening of the stomach is yet not acceptet as a standard screening procedure in Western countries. However, Helicobacter pylori infection is known to increase the risk of developing gastric cancer.
This study will look at the prevalence of Helicobacter pylori infection in asymptomatic patients who have an additional gastroscopy during the same session as their screening colonoscopy. It will also record other early tissue changes or risk factors for stomach cancer, such as intestinal metaplasia and Barrett's mucosa.
The main questions this study aims to answer are:
About 1000 participants are expected to take part. Adults undergoing a screening colonoscopy at a private endoscopy center will be offered the chance to have an additional gastroscopy if they meet the study's inclusion criteria (no previous Helicobacter pylori infection and no upper gastrointestinal symptoms).
Small tissue samples (biopsies) will be taken from the stomach and lower esophagus during the gastroscopy. Biopsies will be checked histologically for the presence of Helicobacter pylori and early tissue changes.
During the gastroscopy, no additional procedures or biopsies will be done beyond what is normally performed during a routine examination. Everything done during this procedure follows the standard steps of a regular gastroscopy.
All data will be coded to protect participant privacy. Researchers will use statistical methods to find out how common Helicobacter pylori infection is and whether it is related to other lifestyle or family risk factors or tissue changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asymptomatic patients undergoing Screening-Colonoscopy | A synchronous gastroscopy performed during colonoscopy at the patient's request to detect Helicobacter pylori infection. |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of asymptomatic patients who are Helicobacter-positive. | All study participants undergo upper gastrointestinal endoscopy (gastroscopy). During the procedure, gastric biopsy specimens are obtained and subsequently processed for histopathological evaluation. The biopsies are analyzed to determine the presence of Helicobacter pylori infection. For statistical analysis, Helicobacter pylori status is coded as follows: absence of infection is recorded as 0, mild infection as 1, moderate infection as 2, and severe infection as 3. | From enrollment to the end of observation at 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic patients who exhibit intestinal metaplasia and/or Barrett's mucosa. | During gastroscopy, biopsy specimens are obtained according to standard endoscopic protocols. Gastric biopsies are histopathologically processed and evaluated for the presence of intestinal metaplasia and Barrett's esophagus. Biopsies obtained from the stomach (Sydney Biopsie Protocol) the ora serrata are likewise histologically examined to identify the presence of Barrett's esophagus and/or intestinal metaplasia.The overall objective of this analysis is to assess the correlation, as well as the strength of the association, between the primary outcome, Helicobacter pylori infection, and the secondary outcomes, namely intestinal metaplasia and Barrett's mucosa. |
| Measure | Description | Time Frame |
|---|---|---|
| Association of BMI, smoking, alcohol consumption, and family history with gastric- and colorectal cancer in relation to Helicobacter pylori infection | The primary outcome of this study is the presence of Helicobacter pylori infection. Other pre-specified outcome measures include potential risk factors such as body mass index (BMI), smoking, alcohol consumption, and family history of gastric and colorectal cancer, all evaluated in relation to Helicobacter pylori. BMI is calculated based on self-reported weight (in kilograms) and height (in meters) using the standard formula: BMI = weight / (height²). Alcohol consumption and smoking habits are recorded through participant self-report, as is family history, which is assessed by asking whether there is a documented occurrence of gastric or colorectal cancer in first-degree relatives. These measures allow the analysis of correlations between Helicobacter pylori infection and established risk factors |
Inclusion Criteria:
Exclusion Criteria:
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Asymptomatic patients without upper gastrointestinal symptoms undergoing a Screening-Colonoscopy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harald Rosen, Univ. Prof. Dr. | Contact | +43 664 4422571 | rosensurg@csi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wiener Privatklinik (WPK) | Recruiting | Vienna | 1090 | Austria |
Due to privacy regulations and restrictions of informed consent, de-identified individual participant data will not be made available.
Additional Documents: Study protocol and statistical analysis plan may be provided upon reasonable request.
December 2025- December 2026 (12 months)
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| From enrollment to the end of observation at 7 days |
| From enrollment to the end of observation at 7 days |