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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02457624
Enrollment
17
Registered
2015-05-29
Start date
2008-03-31
Completion date
2020-12-31
Last updated
2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Gastritis, Atrophic, Intestinal Metaplasia

Keywords

gastric cancer, chronic atrophic gastritis, intestinal metaplasia

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.

Interventions

Experienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Detection rate for gastric premalignant lesion7 years

Secondary

MeasureTime frame
Correlation between endoscopic and serologic diagnosis of premalignant lesions7 years
Inter-observer agreement rate for the diagnosis of premalignant lesions2 months
Detection rate for gastric cancer7 years
Detection rate for gastric dysplasia7 years

Countries

South Korea

Contacts

Primary ContactJoo Hyun Lim, MD.
limz00@gmail.com+82-02-2112-5807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026