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

NCT06707701 | Not Yet Recruiting DMC

• 1 other identifier: 20241102100617911
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Atrophic Gastritis (CAG)

Keywords

chronic atrophic gastritis; global overall symptom scale; serum pepsinogen; operative link for gastritis assessment; operative link for gastric intestinal metaplasia assessment

Outcome Measures

Primary Outcomes (1)

• Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG

  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.

  Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment

Secondary Outcomes (1)

• 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

Interventions

acupuncture OTHER

Whether or not a patient has been treated with acupuncture will be one of the exposure factors of interest in the study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study involved the recruitment of CAG patients from endoscopy centers, outpatient clinics, and inpatient clinics within the Department of Splenology and Gastroenterology at Zhongshan Hospital in Zhejiang Province, designated as the primary recruitment center, along with the First People's Hospital of Hangzhou and Hangzhou Hospital of Traditional Chinese Medicine as secondary recruitment centers.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Liang: lead
• Zhejiang Provincial Department of Science and Technology: collaborator

Study Sites (1)

the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum pepsinogen extracted and detected in venous blood samples

MeSH Terms

Conditions

Gastritis, Atrophic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yi Liang, Doctor

CONTACT

+86 571 86633328; liangyiwww@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: December 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)