Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis

• Conditions: Helicobacter Pylori Gastritis; Autoimmune Diseases; Anemia, Pernicious; Gastritis, Atrophic; Metaplasia
• Interventions: Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains; Diagnostic Test: Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains; Diagnostic Test: The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)

• Registration Number: NCT05238181
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-01
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The autoimmune gastritis group	Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains	Autoimmune gastritis is diagnosed if the anti-parietal cell antibody titer is positive and higher than 1:10 (ImmuGloTM COMVI mouse kidney/stomach IFA kit, Immco Diagnostics, Inc. Buffalo NY, USA).
The autoimmune gastritis group	Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains	Autoimmune gastritis is diagnosed if the anti-parietal cell antibody titer is positive and higher than 1:10 (ImmuGloTM COMVI mouse kidney/stomach IFA kit, Immco Diagnostics, Inc. Buffalo NY, USA).
The controls	The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)	The patients who are enrolled to validate pathogenesis after H. pylori infection. H. pylori infection is diagnosed by histological assessment. The matched controls are needed to be confirmed to have negative anti-parietal cell antibody.
The controls	Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains	The patients who are enrolled to validate pathogenesis after H. pylori infection. H. pylori infection is diagnosed by histological assessment. The matched controls are needed to be confirmed to have negative anti-parietal cell antibody.
The autoimmune gastritis group	The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)	Autoimmune gastritis is diagnosed if the anti-parietal cell antibody titer is positive and higher than 1:10 (ImmuGloTM COMVI mouse kidney/stomach IFA kit, Immco Diagnostics, Inc. Buffalo NY, USA).
The controls	Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains	The patients who are enrolled to validate pathogenesis after H. pylori infection. H. pylori infection is diagnosed by histological assessment. The matched controls are needed to be confirmed to have negative anti-parietal cell antibody.

Primary Outcome Measures

Name	Time	Method
The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining	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	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.

Secondary Outcome Measures

Name	Time	Method
The stages of the Operative Link for Gastritis Assessment (OLGA)	7 days after gastric biopsy	The stages of the Operative Link for Gastritis Assessment (OLGA) defined by updated Sydney are compared between the two groups.
The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM)	7 days after gastric biopsy	The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) defined by updated Sydney are compared between the two groups.
The positive corpus-predominant gastritis index	7 days after gastric biopsy	The rates of positive corpus-predominant gastritis index defined by updated Sydney system are compared between the two groups.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan