Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy (G-SCOGE)
Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa During Screening Colonoscopy - a Cross-sectional Study
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:
- How often is Helicobacter pylori found in adults without upper gastrointestinal symptoms by use of OGD?
- Are there any correlations between H. pylori infection and other risk factors, such as BMI, smoking, alcohol consumption, or a family history of colorectal and/or stomach cancer?
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Harald Rosen, Univ. Prof. Dr.
- Phone Number: +43 664 4422571
- Email: rosensurg@csi.com
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Wiener Privatklinik (WPK)
-
Contact:
- Harald Rosen, Univ. Prof. Dr.
- Phone Number: +43 664 4422571
- Email: rosensurg@csi.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 30 years
- Scheduled screening colonoscopy (either initial screening or surveillance following previously detected polyps)
- Asymptomatic (no gastrointestinal symptoms)
- Willingness and consent to undergo simultaneous gastroscopy with biopsy sampling
- Written informed consent to participate in the study, including the use of histological findings and patient data for study analysis
Exclusion Criteria:
- Known Helicobacter pylori infection or previous treatment for H. pylori
- Current or recent proton pump inhibitor (PPI) therapy (< 4 weeks)
- Pre-existing gastrointestinal diseases (e.g., chronic gastritis, ulcer, gastric carcinoma)
- Immunosuppression or relevant underlying diseases
- Refusal to undergo additional gastroscopy or biopsy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Asymptomatic patients undergoing Screening-Colonoscopy
A synchronous gastroscopy performed during colonoscopy at the patient's request to detect Helicobacter pylori infection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of asymptomatic patients who are Helicobacter-positive.
Time Frame: From enrollment to the end of observation at 7 days
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asymptomatic patients who exhibit intestinal metaplasia and/or Barrett's mucosa.
Time Frame: From enrollment to the end of observation at 7 days
|
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.
|
From enrollment to the end of observation at 7 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association of BMI, smoking, alcohol consumption, and family history with gastric- and colorectal cancer in relation to Helicobacter pylori infection
Time Frame: From enrollment to the end of observation at 7 days
|
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
|
From enrollment to the end of observation at 7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17213538 (Registry Identifier: Endoscopic screening of asymptomatic patients for H. pylori, IM, and Barrett's mucosa during Colonoscopy)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.