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AG & IM in CA Stomach Protocol

Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04184960
Enrollment
400
Registered
2019-12-04
Start date
2019-12-05
Completion date
2024-03-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Gastritis, Gastric Cancer, Intestinal Metaplasia

Keywords

Gastric cancer, Gastroscopy, Atrophic gastritis, Intestinal metaplasia

Brief summary

This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.

Detailed description

The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development. The risk factor assessment would be based on the following criteria. Endoscopic assessment: 1. Atrophic gastritis, based on Kimura Takemoto Classification 2. Kyoto classification of gastritis 3. Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies) 1\. Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia

Interventions

DIAGNOSTIC_TESTGastroscopy and gastric biopsies

Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Two groups of patients would be recruited in this case control study. 1. Gastric neoplasia group Patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia. 2. Control group Patients with no prior history of gastric dysplasia or cancer Inclusion criteria: 1. Age 40 or above 2. Undergo elective upper gastrointestinal endoscopy

Exclusion criteria

1. Patients with history of gastrectomy 2. Patients with severe thrombocytopenia (Platelet count \<50) or coagulopathy (INR \> 1.5 or on anticoagulation) 3. Contraindication to upper gastrointestinal endoscopy 4. Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine) 5. Patients who cannot give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)Cross sectional study, day 0Endoscopic description of severity of gastric atrophy
Endoscopic grading of intestinal metaplasia (EGGIM)Cross sectional study, day 0Endoscopic mapping of degree of intestinal metaplasia
Kyoto classification of gastritisCross sectional study, day 0Descriptive findings of gastritis
Operative links on gastritis assessment (OLGA)Cross sectional study, day 0Biopsy based risk stratification panel based on severity of atrophic gastritis
Operative links on gastric intestinal metaplasia (OLGIM)Cross sectional study, day 0Biopsy based risk stratification panel based on severity of intestinal metaplasia

Countries

Hong Kong, Japan, Singapore, Thailand

Contacts

Primary ContactHon Chi Yip, FRCSEd(Gen)
hcyip@surgery.cuhk.edu.hk+852 35052627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026