The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG

NCT06557252 | Not Yet Recruiting

• 1 other identifier: 2024-091A-01
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  4months

Secondary Outcomes (2)

• Parietal Cell Antibody（PCA）

  4months

• IF-Ab

  4months

Study Arms (2)

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.

Behavioral: PDCA training

Interventions

PDCA training BEHAVIORAL

Improve diagnostic rate

PDCA training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Endoscopy center gastroenterologists in our hospital in 2024

You may qualify if:

• Endoscopy center gastroenterologists in our hospital in 2024

You may not qualify if:

• Doctors who withdrew from the PDCA management midway and stopped undergoing gastroscopy.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo first hospital

Ningbo, Zhejiang, 315000, China

Location

Central Study Contacts

Lei Xu

CONTACT

+8613486659126; xulei22@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 16, 2024
• Study Start: August 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CN (1)