Clinical trial NCT06707701: Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Department of Science and Technology
First posted: 2024-11-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG
timeFrame: Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment
Secondary outcomes:
measure: Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively
timeFrame: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
Study officials:
References: