跳至主要内容
临床试验/NCT05238181
NCT05238181Enrolling By Invitation不适用

To Validate That Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa is a Specific Pathological Feature of Autoimmune Gastritis

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining

研究概览

简要总结

The study is aimed to investigate the different rates of pyloric/ pseudopyloric metaplasia or spasmolytic polypeptide-expressing metaplasia (SPEM) of corpus between autoimmune gastritis and H. pylori-infected non-ulcer dyspepsia.

详细描述

Autoimmune gastritis is not an uncommon disease among northern European ancestry, but its prevalence rates are unclear in other populations, including Taiwanese. A study showed that near 2% of persons more than 60 years old have undiagnosed pernicious anemia, one of the complications of autoimmune gastritis. Believed to be undiagnosed, patients are at risk of gastric malignancy and vitamin B12 deficiency-related complications until the end stage. Therefore, use of available diagnostic tools to diagnose patients with autoimmune gastritis has been important. However, autoimmune gastritis has a silent course and is not easy to be early recognized. Early recognition is important because in the late stage, vitamin B12 replacement treatment may correct pernicious anemia only but not neurologic disorders. Fundus and corpus atrophy with parietal cells loss presented 2 to 3 decades before anemia develops in autoimmune gastritis. It is no doubt that autoimmune gastritis could be diagnosed if vitamin B12 deficiency with megaloblastosis and anemia developed; however, it could be diagnosed earlier if the gastric pathological finding was noticed to be a diagnostic clue. Nevertheless, fundus and corpus atrophy is presented not only in autoimmune gastritis but also in H. pylori-related gastropathy. Therefore, we need a pathologic feature which could help physicians differentiate autoimmune gastritis from H. pylori-infected gastropathy. Here, we propose that pyloric or pseudopyloric metaplasia of corpus is distinct from H. pylori-infected gastropathy. We believe that this specific pathologic feature will be helpful to diagnose patients with autoimmune gastritis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who present with relevant symptoms or signs of upper gastrointestinal diseases, including, but not limited to the following: impaired gastric emptying, epigastric discomfort, postprandial bloating, early satiety, epigastric pain, acid regurgitation, dyspepsia, anemia, or vitamin B12 deficiency, or iron deficiency, are candidates to be enrolled to receive gastroscopy.

排除标准

  • The exclusion criteria are as follows including use of aspirin, non-steroidal anti-inflammatory drugs, or cyclooxygenase-2 selective inhibitors for more than 3 months, or diagnosis with upper gastrointestinal cancer including esophagus, stomach, duodenum, mucosa-associated lymphoid tissue lymphoma, other gastric lymphoma, or pancreas.

结局指标

主要结局

The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining

时间窗: 1 to 3 months after gastric biopsy

The rates of pyloric or pseudopyloric metaplasia of corpus defined by positive TFF2 staining are compared between the two groups

The pyloric or pseudopyloric metaplasia of corpus by H&E staining

时间窗: 7 days after gastric biopsy

The rates of pyloric or pseudopyloric metaplasia of corpus defined by H\&E staining are compared between the two groups.

次要结局

  • The stages of the Operative Link for Gastritis Assessment (OLGA)(7 days after gastric biopsy)
  • The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM)(7 days after gastric biopsy)
  • The positive corpus-predominant gastritis index(7 days after gastric biopsy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiu-Chi Cheng

Professor

National Cheng-Kung University Hospital

研究点 (1)

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