Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa in Autoimmune Gastritis
PM_in_AIG
To Validate That Pyloric or Pseudopyloric Metaplasia of the Corpus Mucosa is a Specific Pathological Feature of Autoimmune Gastritis
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 3, 2023
October 1, 2023
3 years
February 3, 2022
October 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
The positive corpus-predominant gastritis index
7 days after gastric biopsy
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
Study Arms (2)
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).
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.
Interventions
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.
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.
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.
Eligibility Criteria
The patients at the outpatient department or at the inpatient wards of National Cheng Kung University Hospital and Tainan hospital in Tainan, Taiwan, will be selected.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 704302, Taiwan
Related Publications (3)
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.
PMID: 33515301RESULTTsai 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.
PMID: 23550594RESULTCheng 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.
PMID: 28326664RESULT
Biospecimen
whole blood, serum, white cells, gastric tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hsiu-Chi Cheng, MD, PhD
National Cheng-Kung University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 14, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 3, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share