OLGA Stage is More Appropriate in Predicting Early Gastric Cancer

NCT ID: NCT02562976

Last Updated: 2015-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-07-31

Brief Summary

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The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.

Detailed Description

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Japanese endoscopic gastric atrophy (EGA) classification, operative link on Gastritis Assessment (OLGA), operative link on intestinal metaplasia assessment (OLGIM) and gastritis pattern are used in evaluating the severity of gastritis and intestinal metaplasia in different countries, which are risk factors of gastric cancer. The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.

A prospective study was conducted encompassing EGC patients (cases) and non-EGC patients (controls). All patients were performed endoscopic examination and systematically biopsied. Outcome measures were assessed and compared, including EGA classification as well as the OLGA/OLGIM assessment. Helicobacter pylori(H. pylori) status was detected in the meantime. A stepwise logistic regression model was performed to analyze correlations between EGA, OLGA, OLGIM and EGC.

Conditions

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Early Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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early gastric cancer group

use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia in patients with early gastric cancer or high-grade neoplasia(HGN)

gastric atrophy and intestinal metaplasia

Intervention Type OTHER

use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia

non-early gastric cancer group

patients diagnosed as non- gastritis, gastritis or low-grade neoplasia (LGN) by pathology were defined as non-EGC group

gastric atrophy and intestinal metaplasia

Intervention Type OTHER

use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia

Interventions

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gastric atrophy and intestinal metaplasia

use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The age of patients is from 40-80 years
* Must undergo esophagogastroduodenoscopy

Exclusion Criteria

* Clinical diagnosis of advanced gastric cancer
* Post-subtotal gastrectomy
* Acute upper gastrointestinal bleeding
* Severe systemic diseases
* Lack histology
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xiaobo Li

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaobo Li, MD.Ph.D

Role: PRINCIPAL_INVESTIGATOR

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai

Other Identifiers

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rjxhnk3062

Identifier Type: -

Identifier Source: org_study_id

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