Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis

Not yet recruiting

• Conditions: Chronic Atrophic Gastritis (CAG)

• Registration Number: NCT06707701
• Lead Sponsor: Yi Liang

Brief Summary

Brief Summary Template for the Study:

The goal of this observational study is to examine the relationship between digestive symptom scores, serum pepsinogen indices, and histopathological OLGA and OLGIM systematic staging of the gastric mucosa in patients with chronic atrophic gastritis(CAG), aiming to determine the degree of correlation between clinical manifestations, non-invasive laboratory tests, and the gold standard of diagnostic histopathology.To evaluate the comprehensive therapy, readiness and acceptance of acupuncture, utilization rates of various acupuncture therapies, self-assessed efficacy of acupuncture, and endoscopic histopathological alterations in patients with CAG.According to the aforementioned study, it is anticipated to enhance the optimization of acupuncture clinical research protocols for chronic atrophic gastritis, improve treatment efficacy, and offer more effective and rational therapy alternatives for patients.The main question it aims to answer is:

To determine if the outcomes of combined serologic testing of symptoms in patients with CAG can serve as a method for monitoring disease development and if long-term follow-up can be supported？

A group of participants with recorded GI symptom scores and blood pepsinogen levels will respond to online survey questions regarding the severity of their chronic atrophic gastritis progression over the course of 1 year.

Detailed Description

This study is a multicenter cross-sectional pilot survey

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Study Start: 2024-12-30
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Fulfill the diagnostic criteria for chronic atrophic gastritis;
• Individuals aged 18 to 75 years, irrespective of gender;
• Capable of comprehending and consenting to participate in this study by signing the informed consent form.

Exclusion Criteria

• Autoimmune gastritis (type A chronic atrophic gastritis);
• Patients diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy or other examinations or patients diagnosed with high-grade intraepithelial neoplasia by upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
• Patients with confirmed or unable to exclude malignant tumors, especially esophageal and gastric cancers; patients with other upper gastrointestinal tract pathologies such as peptic ulcer or Barrett's esophagus;
• Those who cannot complete the questionnaire due to unconsciousness, inability to communicate normally or other reasons; those with incomplete information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG	Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment	The investigators gathered clinical data on the overall condition, occupation, personal history, family history, H. pylori infection, gastrointestinal symptom scores, serum pepsinogen index, gastroscopy reports, pathological findings, and other biological characteristics of CAG patients, along with data pertaining to acupuncture treatment. The investigators then analyzed the correlation between the gastrointestinal symptom scores, the serum pepsinogen index, and the gastric mucosal histopathology OLGA and OLGIM. The investigators examined the relationship between gastrointestinal symptom scores, serum pepsinogen levels, and the histopathological OLGA and OLGIM stages of gastric mucosa to determine the correlation between clinical manifestations, non-invasive laboratory tests, and the definitive diagnostic standard of histopathology, thereby offering support for clinicians.

Secondary Outcome Measures

Name	Time	Method
Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively	Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months	With the goal of further optimizing the clinical research protocols of acupuncture for CAG, improving the therapeutic effects, and offering a more effective and affordable treatment option for patients with chronic atrophic gastritis, the investigators examined the overall treatment of CAG patients, willingness and acceptance of acupuncture treatment, application rate of various acupuncture therapies, self-perceived acupuncture efficacy, and endoscopic histopathological changes.

Trial Locations

Locations (1)

the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University; 🇨🇳 Hangzhou, China