Clinical trial NCT02457624: Gastric Cancer Screening Quality Improvement System Establishment
Official title: A Prospective Cohort Study for Development of Korean Gastric Cancer Prediction Model and Tailored Gastric Cancer Screening Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Gastritis, Atrophic
Intestinal Metaplasia
Keywords: gastric cancer
chronic atrophic gastritis
intestinal metaplasia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2008 till 2020.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection rate for gastric premalignant lesion
timeFrame: 7 years
Secondary outcomes:
measure: Correlation between endoscopic and serologic diagnosis of premalignant lesions
timeFrame: 7 years
measure: Inter-observer agreement rate for the diagnosis of premalignant lesions
timeFrame: 2 months
measure: Detection rate for gastric cancer
timeFrame: 7 years
measure: Detection rate for gastric dysplasia
timeFrame: 7 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Healthcare System Gangnam Center, Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital
name: Su Jin Chung, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References: