Gastric Cancer Screening Quality Improvement System Establishment

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02457624
Collaborator
(none)
17
1
153
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education and feedback

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
17 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study for Development of Korean Gastric Cancer Prediction Model and Tailored Gastric Cancer Screening Program
Study Start Date :
Mar 1, 2008
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experienced endoscopists

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

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

Outcome Measures

Primary Outcome Measures

  1. Detection rate for gastric premalignant lesion [7 years]

Secondary Outcome Measures

  1. Correlation between endoscopic and serologic diagnosis of premalignant lesions [7 years]

  2. Inter-observer agreement rate for the diagnosis of premalignant lesions [2 months]

  3. Detection rate for gastric cancer [7 years]

  4. Detection rate for gastric dysplasia [7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Healthcare System Gangnam Center, Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Su Jin Chung, MD.PhD., Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Su Jin Chung, Associated Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02457624
Other Study ID Numbers:
  • 1503-044-655
First Posted:
May 29, 2015
Last Update Posted:
Apr 18, 2016
Last Verified:
Apr 1, 2016
Keywords provided by Su Jin Chung, Associated Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2016