Helicobacter Pylori InfectionNCT06397066
White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Hp Infection
An observational study of Helicobacter Pylori Infection, run by Jilin University at 1 site in China.
Trial summary
By comparing the characteristics of Helicobacter pylori (Hp) infection under magnifying endoscopy and white light endoscopy, and making judgments of Hp infection status, the advantages and disadvantages of the two endoscopic examination methods are summarized to improve the accuracy of subsequent endoscopic Hp… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- White light endoscopy group and Magnifying endoscopy group
- Type of treatment
- Surgery or procedure
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Jul 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our endoscopy center conducts magnifying staining endoscopy examination, along with endoscopic Hp immunohistochemical testing, and cases that have recently completed carbon-13 or carbon-14 breath tests.
Who may be able to join
- Our endoscopy center conducts magnifying staining endoscopy examination, along with endoscopic Hp immunohistochemical testing, and cases that have recently completed carbon-13 or carbon-14 breath tests.
Who cannot join
- Total gastric atrophy and endoscopic type A gastritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Helicobacter Pylori Infection
By comparing the characteristics of Helicobacter pylori (Hp) infection under magnifying endoscopy and white light endoscopy, and making judgments of Hp infection status, the advantages and disadvantages of the two endoscopic examination methods are summarized to improve the accuracy of subsequent endoscopic Hp infection status judgments.
Read the detailed description
This study adopts a cross-sectional study. The expected recruitment time for all participants is 12 months. Our endoscopy center conducts magnifying staining endoscopy examination, along with endoscopic Hp immunohistochemical testing, and cases that have recently completed carbon-13 or carbon-14 breath tests.
1.Retrospectively enrolled cases from August 1, 2022 to April 30, 2024, who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University. All enrolled cases had carbon-13 or carbon-14 breath tests, excluding cases of total gastric atrophy and endoscopic type A gastritis. The criteria for determining the status of Hp infection: A positive immunohistochemical or 13/carbon-14 breath test result indicates a current Hp infection. If both of immunohistochemical or 13/carbon-14 breath test result are negative, combined with the treatment history for Hp infection and endoscopic manifestations, they are further classified as non-infection or past H. pylori infection. If there is a treatment history for Hp infection or obvious atrophy under the endoscopy in which atrophy degree greater than or equal to Kimura-Takemoto classification C2 ( atrophy exceeding the gastric angle), it is considered as past H. pylori infection. If there is no such manifestation, it is considered Hp non-infection. Extract the relevant characteristics of Hp infection under white light and magnifying endoscopy from continuous inclusion of cases, and determine the Hp infection status separately. The characteristics of white light endoscopic extraction include degree of atrophy (Kimura-Takemoto classification), congestion and edema, yellow white nodules, mucus turbidity, the arrangement of the collecting veins is regular (RAC)/irregular/disappearing, goose flesh, map-like redness, blood scabs, gastric fundus gland polyps, and scratch syndrome, and are judged according to the Kyoto Classification of Gastritis. Magnifying endoscopy uses NBI+ME to observe the non atrophic area of the gastric fundus gland. According to the proportion of the opening of the gastric fundus gland duct in one magnified field of view, it is classified as grade 1 ≤ 25%, indicating Hp current infection, 25%<grade 2<50%, Hp uncertain state, indicating Hp current infection or after recent sterilization, grade 3 ≥ 50%, indicating Hp non-infection or past H. pylori infection. The investigators conduct a comparative study between white light endoscopy and magnifying endoscopy, and conduct subgroup analysis based on Hp infection status.
Based on the characteristics of white light endoscopy and magnifying endoscopy, summarize and sort out the integrated endoscopic Hp infection status judgment process (named the integrated endoscopic judgment).
Prospective enrollment: From May 1, 2024 to December 31, 2024, patients who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University. All enrolled cases had carbon-13 or carbon-14 breath tests, excluding cases of total gastric atrophy and endoscopic type A gastritis. Using the white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the Hp infection status, three different endoscopic Hp judgment results will be obtained, and data comparison conducted between the three groups.
All enrolled cases were evaluated blindly by two doctors. If there was no consensus, the third doctor would further evaluate and determine the Hp infection status under white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment. Based on the comparison results, a more accurate endoscopic method will be selected to determine the Hp infection status.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- White light endoscopy group, Magnifying endoscopy group
- Keywords
- Hp infection status, magnifying endoscopy, white light endoscopy, immunohistochemical test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White light endoscopy groupProcedure or surgery
White light endoscopy observe the characteristics of mucosa under white light
Magnifying endoscopy groupProcedure or surgery
NBI+ME to observe the non atrophic area of the gastric fundus gland. The results depend on the ratio of gastric fundus gland.
| Study group | Role | What they receive |
|---|---|---|
| the white light endoscopy group | The characteristics of white light endoscopic extraction include degree of atrophy (Kimura-Takemoto classification), congestion and edema, yellow white nodules, mucus turbidity, the arrangement of the collecting veins is regular (RAC)/irregular/disappearing, goose flesh, map-like redness, blood scabs, gastric fundus gland polyps, and scratch syndrome, and are judged according to the Kyoto Classification of Gastritis. Receives: Procedure: White light endoscopy group | |
| the Magnifying endoscopy group | Magnifying endoscopy(ME) uses Narrow Band Imaging (NBI)+ME to observe the non atrophic area of the gastric fundus gland. According to the proportion of the opening of the gastric fundus gland duct in one magnified field of view, it is classified as grade 1 ≤ 25%, indicating Hp current infection, 25%<grade 2<50%, Hp uncertain state, indicating Hp current infection or after recent sterilization, grade 3 ≥ 50%, indicating Hp non-infection or past H. pylori infection. Receives: Procedure: Magnifying endoscopy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of different observation method
white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection status)
Measured: at the end of the observation of endoscopy procedure
Secondary outcomes (4)
Sensitivity of different observation method
white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection)
Measured: at the end of the observation of endoscopy procedure
specificity of different observation method
white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection)
Measured: at the end of the observation of endoscopy procedure
result of immunohistochemistry
Biopsy of Helicobacter pylori from the large and small curvature of the gastric antrum and the large and small curvature of the gastric body, and submission for immunohistochemical detection
Measured: the end of enrollment
result of breath tests.
the results of carbon-13 or carbon-14 breath tests showed the Hp infection status
Measured: the end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 May 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Cross-sectional
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
- Investigators
- Dong Yang, doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397066
- Sponsor's protocol ID
- 130028
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang D, Zhang N, Tao K, Li M, Xu H. Integrated endoscopy: a new method for improving the diagnostic accuracy of Helicobacter pylori infection status. Gastroenterol Rep (Oxf). 2026 Mar 29;14:goag027. doi: 10.1093/gastro/goag027. eCollection 2026 Feb.
PubMed 41913803
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT06397066
- Acronym / sponsor ID
- 130028
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Hp infection status, magnifying endoscopy, white light endoscopy, immunohistochemical test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 2 May 2024 (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.
By comparing the characteristics of Helicobacter pylori (Hp) infection under magnifying endoscopy and white light endoscopy, and making judgments of Hp infection status, the advantages and disadvantages of the two endoscopic examination methods are summarized to improve the accuracy of subsequent endoscopic Hp infection status judgments.
Detailed description
This study adopts a cross-sectional study. The expected recruitment time for all participants is 12 months. Our endoscopy center conducts magnifying staining endoscopy examination, along with endoscopic Hp immunohistochemical testing, and cases that have recently completed carbon-13 or carbon-14 breath tests.
1.Retrospectively enrolled cases from August 1, 2022 to April 30, 2024, who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University. All enrolled cases had carbon-13 or carbon-14 breath tests, excluding cases of total gastric atrophy and endoscopic type A gastritis. The criteria for determining the status of Hp infection: A positive immunohistochemical or 13/carbon-14 breath test result indicates a current Hp infection. If both of immunohistochemical or 13/carbon-14 breath test result are negative, combined with the treatment history for Hp infection and endoscopic manifestations, they are further classified as non-infection or past H. pylori infection. If there is a treatment history for Hp infection or obvious atrophy under the endoscopy in which atrophy degree greater than or equal to Kimura-Takemoto classification C2 ( atrophy exceeding the gastric angle), it is considered as past H. pylori infection. If there is no such manifestation, it is considered Hp non-infection. Extract the relevant characteristics of Hp infection under white light and magnifying endoscopy from continuous inclusion of cases, and determine the Hp infection status separately. The characteristics of white light endoscopic extraction include degree of atrophy (Kimura-Takemoto classification), congestion and edema, yellow white nodules, mucus turbidity, the arrangement of the collecting veins is regular (RAC)/irregular/disappearing, goose flesh, map-like redness, blood scabs, gastric fundus gland polyps, and scratch syndrome, and are judged according to the Kyoto Classification of Gastritis. Magnifying endoscopy uses NBI+ME to observe the non atrophic area of the gastric fundus gland. According to the proportion of the opening of the gastric fundus gland duct in one magnified field of view, it is classified as grade 1 ≤ 25%, indicating Hp current infection, 25%<grade 2<50%, Hp uncertain state, indicating Hp current infection or after recent sterilization, grade 3 ≥ 50%, indicating Hp non-infection or past H. pylori infection. The investigators conduct a comparative study between white light endoscopy and magnifying endoscopy, and conduct subgroup analysis based on Hp infection status.
Based on the characteristics of white light endoscopy and magnifying endoscopy, summarize and sort out the integrated endoscopic Hp infection status judgment process (named the integrated endoscopic judgment).
Prospective enrollment: From May 1, 2024 to December 31, 2024, patients who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University. All enrolled cases had carbon-13 or carbon-14 breath tests, excluding cases of total gastric atrophy and endoscopic type A gastritis. Using the white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the Hp infection status, three different endoscopic Hp judgment results will be obtained, and data comparison conducted between the three groups.
All enrolled cases were evaluated blindly by two doctors. If there was no consensus, the third doctor would further evaluate and determine the Hp infection status under white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment. Based on the comparison results, a more accurate endoscopic method will be selected to determine the Hp infection status.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the white light endoscopy group | – | Procedure: White light endoscopy groupThe characteristics of white light endoscopic extraction include degree of atrophy (Kimura-Takemoto classification), congestion and edema, yellow white nodules, mucus turbidity, the arrangement of the collecting veins is regular (RAC)/irregular/disappearing, goose flesh, map-like redness, blood scabs, gastric fundus gland polyps, and scratch syndrome, and are judged according to the Kyoto Classification of Gastritis. |
| the Magnifying endoscopy group | – | Procedure: Magnifying endoscopy groupMagnifying endoscopy(ME) uses Narrow Band Imaging (NBI)+ME to observe the non atrophic area of the gastric fundus gland. According to the proportion of the opening of the gastric fundus gland duct in one magnified field of view, it is classified as grade 1 ≤ 25%, indicating Hp current infection, 25%<grade 2<50%, Hp uncertain state, indicating Hp current infection or after recent sterilization, grade 3 ≥ 50%, indicating Hp non-infection or past H. pylori infection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our endoscopy center conducts magnifying staining endoscopy examination, along with endoscopic Hp immunohistochemical testing, and cases that have recently completed carbon-13 or carbon-14 breath tests.
Key inclusion criteria (1 listed)
- Our endoscopy center conducts magnifying staining endoscopy examination, along with endoscopic Hp immunohistochemical testing, and cases that have recently completed carbon-13 or carbon-14 breath tests.
Key exclusion criteria (1 listed)
- Total gastric atrophy and endoscopic type A gastritis.
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 |
|---|---|---|
| White light endoscopy groupWhite light endoscopy observe the characteristics of mucosa under white light | Procedure or surgery | the white light endoscopy group |
| Magnifying endoscopy groupNBI+ME to observe the non atrophic area of the gastric fundus gland. The results depend on the ratio of gastric fundus gland. | Procedure or surgery | the Magnifying endoscopy group |
Primary outcome
Accuracy of different observation method
Time frame: at the end of the observation of endoscopy procedure
white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection status)
4 secondary outcomes
Sensitivity of different observation method
Time frame: at the end of the observation of endoscopy procedure
specificity of different observation method
Time frame: at the end of the observation of endoscopy procedure
result of immunohistochemistry
Time frame: the end of enrollment
result of breath tests.
Time frame: the end of enrollment
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 6 Aug 2026.
- Derived from this study: PubMed 41913803Yang D, Zhang N, Tao K, Li M, Xu H. Integrated endoscopy: a new method for improving the diagnostic accuracy of Helicobacter pylori infection status. Gastroenterol Rep (Oxf). 2026 Mar 29;14:goag027. doi: 10.1093/gastro/goag027. eCollection 2026 Feb.
- Individual participant dataSharing planned: No
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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.
Dong Yang, doctor principal investigator
The First Hospital of Jilin University
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 Pylori Infection, run by Jilin University at 1 site in China.
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 1 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 6 Aug 2026. 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 China. 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?
Accuracy of different observation method (time frame: at the end of the observation of endoscopy procedure). 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 NCT06397066, which also lists 1 linked publication.
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 6 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.