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

November 27, 2024 updated by: Yi Liang

Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis:a Multicenter Cross-sectional Pilot Survey

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter cross-sectional pilot survey

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG
Time Frame: 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.
Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively
Time Frame: 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.
Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Liang

Collaborators

Zhejiang Provincial Department of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20241102100617911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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