AG & IM in CA Stomach Protocol

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Atrophic Gastritis

Gastric Cancer

Intestinal Metaplasia

Treatments

Diagnostic Test: Gastroscopy and gastric biopsies

Study type

Observational

Funder types

Other

Identifiers

NCT04184960

CRE-2019.341

Details and patient eligibility

About

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.

Full 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:

Atrophic gastritis, based on Kimura Takemoto Classification
Kyoto classification of gastritis
Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies)
Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia

Enrollment

400 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Two groups of patients would be recruited in this case control study.

Gastric neoplasia group Patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia.
Control group Patients with no prior history of gastric dysplasia or cancer

Inclusion criteria:

Age 40 or above
Undergo elective upper gastrointestinal endoscopy

Exclusion criteria:

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