Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis
NCT ID: NCT05238181
Last Updated: 2023-10-03
Study Results
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Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2022-01-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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The autoimmune gastritis group
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).
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.
The controls
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
20 Years
90 Years
ALL
No
Sponsors
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Tainan Hospital, Ministry of Health and Welfare
OTHER
National Cheng-Kung University Hospital
OTHER
Responsible Party
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Hsiu-Chi Cheng
Professor
Principal Investigators
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Hsiu-Chi Cheng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cheng-Kung University Hospital
Locations
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National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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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 series of 22 Japanese patients. Virchows Arch. 2021 Jul;479(1):169-178. doi: 10.1007/s00428-021-03033-5. Epub 2021 Jan 30.
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: 10.1111/apt.12291. Epub 2013 Apr 2.
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 Aug;22(4). doi: 10.1111/hel.12385. Epub 2017 Mar 22.
Other Identifiers
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B-ER-110-440
Identifier Type: -
Identifier Source: org_study_id
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