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Набор скоро начнётся NCT06707701

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

— Наблюдательное Chronic Atrophic Gastritis (CAG)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: acupuncture.
Кому может быть актуально
Состояния в реестре: Chronic Atrophic Gastritis (CAG). Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

This study is a multicenter cross-sectional pilot survey

Вмешательства

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

Первичные конечные точки

  • Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG [Срок оценки: Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment]
Вторичные конечные точки (1)
  • Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively [Срок оценки: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Ханчжоу

Идентификаторы

NCT: NCT06707701 · 20241102100617911

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗