Autoimmune GastritisNCT06557252
The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG
An observational study of Autoimmune Gastritis, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Gastritis
- What is being tested?
- PDCA training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Endoscopy center gastroenterologists in our hospital in 2024
Who may be able to join
- Endoscopy center gastroenterologists in our hospital in 2024
Who cannot join
- Doctors who withdrew from the PDCA management midway and stopped undergoing gastroscopy.
Trial locations and contacts
1 site in 1 country.
China1 site
Ningbo first hospital
Ningbo, Zhejiang, 315000
Lei Xu, MD, +86-13486659126, xulei22@163.com
About this study
Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. It can also be complicated by hyperplastic gastric polyps, gastric neuroendocrine tumors, gastric adenocarcinoma, and other diseases, making it prone to clinical misdiagnosis. As a form of gastritis in the post-Helicobacter pylori era, its detection rate has been gradually increasing with the continuous improvement of endoscopic technology in China. Applying the PDCA cycle management in disease diagnosis can significantly improve the detection rate of the disease, benefiting patients. Through the PDCA management model, this study further enhanced gastroenterologists' understanding of this disease from various aspects, aiming to improve the clinical diagnosis of autoimmune gastritis.
- Conditions
- Autoimmune Gastritis
- Being tested
- PDCA training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDCA trainingBehavioural
Improve diagnostic rate
| Study group | Role | What they receive |
|---|---|---|
| not received PDCA training | no intervention | |
| PDCA training | The group of endoscopists underwent PDCA training to observe whether it ultimately improved the diagnosis rate of autoimmune gastritis. Receives: Behavioral: PDCA training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of AIG
To diagnose Autoimmune Gastritis (AIG), the following two criteria must be simultaneously met:
Endoscopic or histopathological findings, or both, that are consistent with the characteristics of autoimmune gastritis.
Positive gastric autoantibody status, including the presence of anti-parietal cell antibodies (PCA) or anti-intrinsic factor antibodies (IFA), or both.
Measured: 4months
The suspected diagnosis rate of AIG
If only the endoscopic or histopathological findings, or both, are consistent with the characteristics of autoimmune gastritis, but the gastric autoantibody status (anti-parietal cell antibodies or anti-intrinsic factor antibodies) is not confirmed to be positive, then the case should be considered as a suspected case of Autoimmune Gastritis (AIG).
Measured: 4months
Secondary outcomes (2)
Parietal Cell Antibody（PCA）
PCA is an important indicator in the diagnosis of AIG.
Measured: 4months
IF-Ab
IFA is an important indicator in the diagnosis of AIG.
Measured: 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Autoimmune 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557252
- Sponsor's protocol ID
- 2024-091A-01
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu Y, Wang S, Yu Q, Zheng S, Zhang Z, Xu L, Lin P. The Application of the Plan-Do-Check-Act Management Model in Improving the Diagnostic Yield of Autoimmune Gastritis. Dig Dis Sci. 2026 May 6. doi: 10.1007/s10620-026-09956-w. Online ahead of print.
PubMed 42087017
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG
- ClinicalTrials.gov ID
- NCT06557252
- Acronym / sponsor ID
- 2024-091A-01
- Conditions
- Autoimmune Gastritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Aug 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.
Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. It can also be complicated by hyperplastic gastric polyps, gastric neuroendocrine tumors, gastric adenocarcinoma, and other diseases, making it prone to clinical misdiagnosis. As a form of gastritis in the post-Helicobacter pylori era, its detection rate has been gradually increasing with the continuous improvement of endoscopic technology in China. Applying the PDCA cycle management in disease diagnosis can significantly improve the detection rate of the disease, benefiting patients. Through the PDCA management model, this study further enhanced gastroenterologists' understanding of this disease from various aspects, aiming to improve the clinical diagnosis of autoimmune gastritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| not received PDCA training | – | –no intervention |
| PDCA training | – | Behavioral: PDCA trainingThe group of endoscopists underwent PDCA training to observe whether it ultimately improved the diagnosis rate of autoimmune gastritis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Endoscopy center gastroenterologists in our hospital in 2024
Key inclusion criteria (1 listed)
- Endoscopy center gastroenterologists in our hospital in 2024
Key exclusion criteria (1 listed)
- Doctors who withdrew from the PDCA management midway and stopped undergoing gastroscopy.
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 |
|---|---|---|
| PDCA trainingImprove diagnostic rate | Behavioural | PDCA training |
Primary outcome
Diagnostic Accuracy of AIG
Time frame: 4months
To diagnose Autoimmune Gastritis (AIG), the following two criteria must be simultaneously met: Endoscopic or histopathological findings, or both, that are consistent with the characteristics of autoimmune gastritis. Positive gastric autoantibody status, including the presence of anti-parietal cell antibodies (PCA) or anti-intrinsic factor antibodies (IFA), or both.
The suspected diagnosis rate of AIG
Time frame: 4months
If only the endoscopic or histopathological findings, or both, are consistent with the characteristics of autoimmune gastritis, but the gastric autoantibody status (anti-parietal cell antibodies or anti-intrinsic factor antibodies) is not confirmed to be positive, then the case should be considered as a suspected case of Autoimmune Gastritis (AIG).
2 secondary outcomes
Parietal Cell Antibody（PCA）
Time frame: 4months
IF-Ab
Time frame: 4months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Derived from this study: PubMed 42087017Zhu Y, Wang S, Yu Q, Zheng S, Zhang Z, Xu L, Lin P. The Application of the Plan-Do-Check-Act Management Model in Improving the Diagnostic Yield of Autoimmune Gastritis. Dig Dis Sci. 2026 May 6. doi: 10.1007/s10620-026-09956-w. Online ahead of print.
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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.
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 Autoimmune Gastritis, run by Ningbo No. 1 Hospital 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Xu (+8613486659126, xulei22@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of AIG (time frame: 4months). 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?
On the ClinicalTrials.gov record for NCT06557252, 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 16 Aug 2024.