OLGA Stage is More Appropriate in Predicting Early Gastric Cancer

Early Gastric Cancer Clinical Trial

Official title:

OLGA Stage is More Appropriate in Predicting Early Gastric Cancer Than Endoscopic Gastric Atrophy Classification and OLGIM Stage: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562976
• Other study ID #: rjxhnk3062
• Status: Completed
• Phase: N/A
• First received: September 22, 2015
• Last updated: September 27, 2015
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with severe gastric atrophy and/or intestinal metaplasia in early gastric cancer and non-early gastric cancer	use the Japanese endoscopic gastric atrophy (EGA) classification(it has 6 stages-C1,C2,C3,O1,O2,O3), Operative Link on Gastritis Assessment (OLGA,it has 4 stages-I,II,III,IV), and Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM,it has 4 stages-I,II,III,IV) to pick out severe gastric atrophy and/or intestinal metaplasia(EGA stage C3-O3,OLGA/OLGIM stage III-IV)	up to 27 months	Yes
Secondary	correlations between Japanese endoscopic gastric atrophy (EGA) classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) and early gastric cancer		up to 27 months	Yes
Secondary	correlations between Helicobacter pylori infection and moderate-to-severe EGA classification, OLGA stage III-IV, OLGIM stage III-IV	EGA means endoscopic gastric atrophy classification,OLGA means Operative Link on Gastritis Assessment, and OLGIM means Operative Link on Gastric Intestinal Metaplasia Assessment	up to 27 months	Yes