OLGA Stage is More Appropriate in Predicting Early Gastric Cancer

NCT02562976 | Completed DMC

• 1 other identifier: rjxhnk3062
• Study Type: observational
• Target: 227
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• correlations between Helicobacter pylori infection and moderate-to-severe EGA classification, OLGA stage III-IV, OLGIM stage III-IV

  up to 27 months

Study Arms (2)

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)

Other: 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

Other: gastric atrophy and intestinal metaplasia

Interventions

gastric atrophy and intestinal metaplasia 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

early gastric cancer group; non-early gastric cancer group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study involved consecutive patients from 40-80 years who undergoing esophagogastroduodenoscopy

You may qualify if:

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

You may not qualify if:

• Clinical diagnosis of advanced gastric cancer
• Post-subtotal gastrectomy
• Acute upper gastrointestinal bleeding
• Severe systemic diseases
• Lack histology

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xiaobo Li, MD.Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 29, 2015
• Study Start: May 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09