NCT02457624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

12.1 years

First QC Date

March 25, 2015

Last Update Submit

April 14, 2016

Conditions

Keywords

gastric cancerchronic atrophic gastritisintestinal metaplasia

Outcome Measures

Primary Outcomes (1)

  • Detection rate for gastric premalignant lesion

    7 years

Secondary Outcomes (4)

  • Correlation between endoscopic and serologic diagnosis of premalignant lesions

    7 years

  • Inter-observer agreement rate for the diagnosis of premalignant lesions

    2 months

  • Detection rate for gastric cancer

    7 years

  • Detection rate for gastric dysplasia

    7 years

Study Arms (1)

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

Interventions

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

Experienced endoscopists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsGastritis, Atrophic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGastritisGastroenteritis

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Su Jin Chung, MD.PhD.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Hyun Lim, MD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

March 25, 2015

First Posted

May 29, 2015

Study Start

March 1, 2008

Primary Completion

April 1, 2020

Study Completion

December 1, 2020

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations