Gastric Cancer Screening Quality Improvement System Establishment

NCT ID: NCT02457624

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Gastric Cancer Gastritis, Atrophic Intestinal Metaplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experienced endoscopists

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

Education and feedback

Intervention Type BEHAVIORAL

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

Interventions

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Education and feedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Su Jin Chung

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Su Jin Chung, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital

Locations

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Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joo Hyun Lim, MD.

Role: CONTACT

+82-02-2112-5807

Facility Contacts

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Joo Hyun Lim, M.D.

Role: primary

82-2-2112-5807

Other Identifiers

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1503-044-655

Identifier Type: -

Identifier Source: org_study_id

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