Gastritis H PyloriNCT04489030
Magnifying NBI Endoscopy for Gastric Condition
An observational study of Gastritis H Pylori, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastritis H Pylori
- What is being tested?
- Magnifying narrow-band imaging endoscopy
- How many people
- 254 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to 31 Aug 2020
- 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: All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.
Who may be able to join
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
Who cannot join
- Age < 20 or > 70 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- History of H. pylori eradication
- History of gastric surgery
- Recent history of upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnifying Narrow-band Imaging for Diagnosis of H. Pylori and Precancerous Gastric Conditions: Comparison With Standard Endoscopy
Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was 91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous gastric lesions between standard and magnifying endoscopy.
Read the detailed description
The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard endoscopy for predicting H. pylori-infection status and precancerous gastric conditions, compared to magnifying NBI endoscopy
- Conditions
- Gastritis H Pylori
- Being tested
- Magnifying narrow-band imaging endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnifying narrow-band imaging endoscopyOther
During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori infection status
- pylori positivity would be assessed using rapid urease test.
Measured: 1 month
Degree of chronic gastritis
Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jun 2016
- Primary completion30 Apr 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis H PyloriStudies 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Digestive Disease Center, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489030
- Sponsor's protocol ID
- SCH-NBI endoscopy
- Status last verified
- Sep 2020
- First submitted
- 24 Jul 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnifying Narrow-band Imaging for Diagnosis of H. Pylori and Precancerous Gastric Conditions: Comparison With Standard Endoscopy
- ClinicalTrials.gov ID
- NCT04489030
- Acronym / sponsor ID
- SCH-NBI endoscopy
- Conditions
- Gastritis H Pylori
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Jul 2020 (actual)
- 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.
Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was 91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous gastric lesions between standard and magnifying endoscopy.
Detailed description
The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard endoscopy for predicting H. pylori-infection status and precancerous gastric conditions, compared to magnifying NBI endoscopy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a single academic hospital.
Key inclusion criteria (2 listed)
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
Key exclusion criteria (8 listed)
- Age < 20 or > 70 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnifying narrow-band imaging endoscopyDuring endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging. | Other | – |
Primary outcome
H. pylori infection status
Time frame: 1 month
H. pylori positivity would be assessed using rapid urease test.
Degree of chronic gastritis
Time frame: 1 month
Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).
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 29 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Gastritis H Pylori
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
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NLR and PLR in H. Pylori-Associated Gastritis
Helicobacter Pylori Infection, Gastritis
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The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
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A Prospective Cohort Study on Endoscopic Features of Upper Gastrointestinal Tract at High Altitude (Zaduo County)
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Not yet recruitingPhase 4
Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
Helicobacter Pylori Infection, Peptic Ulcer Disease
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
Digestive Disease Center, Soonchunhyang 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 Gastritis H Pylori, run by Soonchunhyang University Hospital 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 2 inclusion and 8 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 29 Sep 2020. 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?
H. pylori infection status (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2020.