NCT02457624

Gastric Cancer Screening Quality Improvement System Establishment

A Prospective Cohort Study for Development of Korean Gastric Cancer Prediction Model and Tailored Gastric Cancer Screening Program

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 17 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastric Cancer
• Gastritis, Atrophic
• Intestinal Metaplasia

Interventions

Type	Name	Description
BEHAVIORAL	Education and feedback	Experienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests.

Timeline

• Start date: 2008-03-01
• Primary completion: 2020-04-01
• Completion: 2020-12-01
• First posted: 2015-05-29
• Last updated: 2016-04-18

Locations

1 site across 1 country: South Korea