Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis

NCT05238181 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-10-03

No results posted yet for this study

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.

Conditions

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

Interventions

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.

DIAGNOSTIC_TEST

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.

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)

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.

Sponsors & Collaborators

  • Tainan Hospital, Ministry of Health and Welfare

    collaborator OTHER
  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Hsiu-Chi Cheng, MD, PhD · National Cheng-Kung University Hospital

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238181 on ClinicalTrials.gov