Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis

Autoimmune Diseases Clinical Trial

— PM_in_AIG  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05238181
• Other study ID #: B-ER-110-440
• Status: Enrolling by invitation
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Gastritis
• Gastritis, Atrophic
• Helicobacter Pylori Gastritis
• Metaplasia

Intervention

Diagnostic Test:
• Assess pyloric or pseudopyloric metaplasia of corpus by H&E stains
The pathologists assess pyloric or pseudopyloric metaplasia. Pyloric or pseudopyloric metaplasia of corpus is defined as the presence of torturous deep glands in a "pseudo-pylori" pattern with focal or complete loss of parietal cells. The score of pyloric or pseudopyloric metaplasia of the corpus mucosa is ranging from 0 to 3. Score 0 is no loss of parietal cells with normal fundus gland patterns. Score 1 presents focal loss of parietal cells and scattered patterns of pyloric or pseudopyloric metaplasia with few forming pylorus-like glands. Score 2 presents focal loss of parietal cells and scattered patterns of pyloric or pseudopyloric metaplasia mixed with >= 4 pylorus-like glands. Score 3 was clusters of pylorus-like glands; the metaplasia involves > 60% of mucosa and extends to the lower third of mucosa.
• Assess pyloric or pseudopyloric metaplasia of corpus by TFF2 immunohistochemistry stains
Mouse anti-human TFF2 monoclonal antibody (R&D Systems) is used to stain gastric corpus tissues to assess the presence and degree of SPEM. The score of TFF2 staining of the corpus mucosa is ranging from 0 to 3. Score 0 is not stained. Score 1 is a "scattered" pattern of TFF staining between parietal cells; the staining is limited in the middle third of the mucosa. Score 2 is TFF2-expressing cells distributed over both the middle and lower third of the glands. Score 3 is torturous gastric oxyntic glands with a diffuse expression of TFF2 into the whole glands over both the middle and lower third of the glands of the mucosa.
• The assessment of corpus-predominant gastritis index (CGI), Operative Link for Gastritis Assessment (OLGA), and Operative Link on Gastric Intestinal Metaplasia assessment (OLGIM)
We take five gastric mucosal biopsies in each patient under gastroscopy, including two from the antrum (at the lesser and greater curvature, 2 cm within the pylorus, respectively), two from the corpus (at the lesser curvature of the lower corpus and the greater curvature of the middle corpus, respectively), and one from the lesser curvature of the high corpus. The pathologists assess the gastric pathology according to the updated Sydney system. Accordingly, the histological findings are translated into CGI, the Operative Link for Gastritis Assessment (OLGA), and the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) stages.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	Tainan Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Cheng HC, Tsai YC, Yang HB, Yeh YC, Chang WL, Kuo HY, Lu CC, Sheu BS. The corpus-predominant gastritis index can be an early and reversible marker to identify the gastric cancer risk of Helicobacter pylori-infected nonulcer dyspepsia. Helicobacter. 2017 A — View Citation

Tsai YC, Hsiao WH, Yang HB, Cheng HC, Chang WL, Lu CC, Sheu BS. The corpus-predominant gastritis index may serve as an early marker of Helicobacter pylori-infected patients at risk of gastric cancer. Aliment Pharmacol Ther. 2013 May;37(10):969-78. doi: 10 — View Citation

Wada Y, Nakajima S, Kushima R, Takemura S, Mori N, Hasegawa H, Nakayama T, Mukaisho KI, Yoshida A, Umano S, Yamamoto K, Sugihara H, Murakami K. Pyloric, pseudopyloric, and spasmolytic polypeptide-expressing metaplasias in autoimmune gastritis: a case seri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pyloric or pseudopyloric metaplasia of corpus by positive TFF2 staining	The rates of pyloric or pseudopyloric metaplasia of corpus defined by positive TFF2 staining are compared between the two groups	1 to 3 months after gastric biopsy
Primary	The pyloric or pseudopyloric metaplasia of corpus by H&E staining	The rates of pyloric or pseudopyloric metaplasia of corpus defined by H&E staining are compared between the two groups.	7 days after gastric biopsy
Secondary	The positive corpus-predominant gastritis index	The rates of positive corpus-predominant gastritis index defined by updated Sydney system are compared between the two groups.	7 days after gastric biopsy
Secondary	The stages of the Operative Link for Gastritis Assessment (OLGA)	The stages of the Operative Link for Gastritis Assessment (OLGA) defined by updated Sydney are compared between the two groups.	7 days after gastric biopsy
Secondary	The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM)	The stages of the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) defined by updated Sydney are compared between the two groups.	7 days after gastric biopsy