Clinical trial NCT02562976: OLGA Stage is More Appropriate in Predicting Early Gastric Cancer
Official title: OLGA Stage is More Appropriate in Predicting Early Gastric Cancer Than Endoscopic Gastric Atrophy Classification and OLGIM Stage: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Gastric Cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 227
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involved consecutive patients from 40-80 years who undergoing esophagogastroduodenoscopy

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with severe gastric atrophy and/or intestinal metaplasia in early gastric cancer and non-early gastric cancer
timeFrame: up to 27 months
Secondary outcomes:
measure: 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
timeFrame: up to 27 months
measure: correlations between Helicobacter pylori infection and moderate-to-severe EGA classification, OLGA stage III-IV, OLGIM stage III-IV
timeFrame: up to 27 months
Other outcomes:
Locations:
Study officials:
affiliation: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai
name: Xiaobo Li, MD.Ph.D
role: PRINCIPAL_INVESTIGATOR
References: