Helicobacter-associated GastritisNCT01434992
Detection of Helicobacter Pylori Infection by High Resolution Endoscopy
An observational study of Helicobacter-associated Gastritis, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Helicobacter-associated Gastritis
- How many people
- 585 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent upper endoscopy in the Kyung Hee University Hospital
Who may be able to join
- Patients who underwent upper endoscopy
Who cannot join
- Age < 20 or > 70
- Severe systemic disease or advanced chronic liver disease
- Medication history of NSAID, PPI, H2 blockers or antibiotics
- History of H. pylori eradication therapy
- History of gastric surgery
- Recent history of upper GI bleeding
Show all 9Show fewer
- Gastric or duodenal ulcer (including old scar change) during endoscopy
- Anemia (Hemoglobin level < 10mg/dL)
- Pangastritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus
Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.
Read the detailed description
Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.
- Conditions
- Helicobacter-associated Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori gastritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis accuracy for predicting of Helicobacter pylori infection status
Measured: 1 day
Secondary outcomes (1)
Assessment of the clinicopathologic factors related to correct diagnosis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Helicobacter-associated GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Kyunghee University Medical Center
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434992
- Sponsor's protocol ID
- KHU-HP-2011
- Status last verified
- Apr 2012
- First submitted
- 14 Sep 2011
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bah A, Saraga E, Armstrong D, Vouillamoz D, Dorta G, Duroux P, Weber B, Froehlich F, Blum AL, Schnegg JF. Endoscopic features of Helicobacter pylori-related gastritis. Endoscopy. 1995 Oct;27(8):593-6. doi: 10.1055/s-2007-1005764.
PubMed 8608753Redeen S, Petersson F, Jonsson KA, Borch K. Relationship of gastroscopic features to histological findings in gastritis and Helicobacter pylori infection in a general population sample. Endoscopy. 2003 Nov;35(11):946-50. doi: 10.1055/s-2003-43479.
PubMed 14606018Mihara M, Haruma K, Kamada T, Komoto K, Yoshihara M, Sumii K, Kajiyama G. The role of endoscopic findings for the diagnosis of Helicobacter pylori infection: evaluation in a country with high prevalence of atrophic gastritis. Helicobacter. 1999 Mar;4(1):40-8. doi: 10.1046/j.1523-5378.1999.09016.x.
PubMed 10352086Cho JH, Chang YW, Jang JY, Shim JJ, Lee CK, Dong SH, Kim HJ, Kim BH, Lee TH, Cho JY. Close observation of gastric mucosal pattern by standard endoscopy can predict Helicobacter pylori infection status. J Gastroenterol Hepatol. 2013 Feb;28(2):279-84. doi: 10.1111/jgh.12046.
PubMed 23189930
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus
- ClinicalTrials.gov ID
- NCT01434992
- Acronym / sponsor ID
- KHU-HP-2011
- Conditions
- Helicobacter-associated Gastritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.
Detailed description
Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H. pylori gastritis | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent upper endoscopy in the Kyung Hee University Hospital
Key inclusion criteria (1 listed)
- Patients who underwent upper endoscopy
Key exclusion criteria (9 listed)
- Age < 20 or > 70
- Severe systemic disease or advanced chronic liver disease
- Medication history of NSAID, PPI, H2 blockers or antibiotics
- History of H. pylori eradication therapy
- History of gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis accuracy for predicting of Helicobacter pylori infection status
Time frame: 1 day
1 secondary outcome
Assessment of the clinicopathologic factors related to correct diagnosis
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Background: PubMed 8608753Bah A, Saraga E, Armstrong D, Vouillamoz D, Dorta G, Duroux P, Weber B, Froehlich F, Blum AL, Schnegg JF. Endoscopic features of Helicobacter pylori-related gastritis. Endoscopy. 1995 Oct;27(8):593-6. doi: 10.1055/s-2007-1005764.
- Background: PubMed 14606018Redeen S, Petersson F, Jonsson KA, Borch K. Relationship of gastroscopic features to histological findings in gastritis and Helicobacter pylori infection in a general population sample. Endoscopy. 2003 Nov;35(11):946-50. doi: 10.1055/s-2003-43479.
- Background: PubMed 10352086Mihara M, Haruma K, Kamada T, Komoto K, Yoshihara M, Sumii K, Kajiyama G. The role of endoscopic findings for the diagnosis of Helicobacter pylori infection: evaluation in a country with high prevalence of atrophic gastritis. Helicobacter. 1999 Mar;4(1):40-8. doi: 10.1046/j.1523-5378.1999.09016.x.
- Derived from this study: PubMed 23189930Cho JH, Chang YW, Jang JY, Shim JJ, Lee CK, Dong SH, Kim HJ, Kim BH, Lee TH, Cho JY. Close observation of gastric mucosal pattern by standard endoscopy can predict Helicobacter pylori infection status. J Gastroenterol Hepatol. 2013 Feb;28(2):279-84. doi: 10.1111/jgh.12046.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Hyung Cho, M.D. principal investigator
Kyung Hee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter-associated Gastritis, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis accuracy for predicting of Helicobacter pylori infection status (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01434992, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.