Gastric Cancer Screening Quality Improvement System Establishment

• Conditions: Intestinal Metaplasia; Gastric Cancer; Gastritis, Atrophic
• Interventions: Behavioral: Education and feedback

• Registration Number: NCT02457624
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Experienced endoscopists will perform endoscopy during the study period and the detection rate of gastric premalignant lesion, correlation between endoscopic and serologic diagnosis of premalignant lesions and inter-observer agreement rate will be analyzed before and after the education.

Detailed Description

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods. First, the detection rate of gastric premalignant lesions and the correlation between endoscopic and serologic diagnosis of premalignant lesions will be analyzed retrospectively from March 2008 till February 2009 and from March 2013 till February 2014, when the levels of serum pepsinogen were achieved from the patients. In the second period from March 2015 till April 2015, quality assurance program will be activated. Endoscopists will be educated on the Kimura-Takemoto classification for chronic atrophic gastritis. After that their diagnosis will be tested and they will have feedback and discussion all together. In this period, inter-observer agreement rate will be assessed serially. Third, prospective trial will run from May 2015 till April 2020, in which all the endoscopists' detection rate of gastric premalignant lesion, the correlation between endoscopic and serologic diagnosis of premalignant lesions, and their inter-observer agreement will be analyzed. Finally, cumulative incidence and mortality rate of gastric cancer and incidence rate of gastric dysplasia will be investigated until December 2020.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18
• Primary Completion: 2020-04
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients who received endoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.

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Exclusion Criteria

• Age < 18 years
• Those who refused to be included in the research
• History of gastric cancer
• Current medication with proton pump inhibitor, non-steroidal anti-inflammatory drug or aspirin
• Active/healing stage of gastric ulcer or gastric ulcer scar
• Active/healing stage of duodenal ulcer
• History of previous surgical or endoscopic resection of stomach

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experienced endoscopists	Education and feedback	All the experienced endoscopists will receive education and feedback on the diagnosis for premalignant lesion of chronic atrophic gastritis and intestinal metaplasia

Primary Outcome Measures

Name	Time	Method
Detection rate for gastric premalignant lesion	7 years

Secondary Outcome Measures

Name	Time	Method
Correlation between endoscopic and serologic diagnosis of premalignant lesions	7 years
Inter-observer agreement rate for the diagnosis of premalignant lesions	2 months
Detection rate for gastric cancer	7 years
Detection rate for gastric dysplasia	7 years

Trial Locations

Locations (1)

Healthcare System Gangnam Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of