NCT02044536

Brief Summary

The optimal number of biopsy and the detection rate of neoplastic lesions are not established. The aim of this study is to assess the current practice pattern and effect of training in upper endoscopic biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

Same day

First QC Date

January 22, 2014

Last Update Submit

October 23, 2018

Conditions

Neoplasm

Keywords

biopsyendoscopyneoplasms

Outcome Measures

Primary Outcomes (1)

  • Concordance rate of endoscopic diagnosis and histologic diagnosis

    In the evaluation of concordance rate and discrepancy rate, endoscopic diagnosis in the procedure report and histologic diagnosis in the pathology report will be compared.

    During 3 months (retrospective endoscopy data review)

Secondary Outcomes (1)

  • Neoplastic lesion detection rate

    During 3 months (retrospetive endoscopy data review)

Other Outcomes (1)

  • Distribution of the biopsied lesion

    During 3 months (retrospective endoscopy data review)

Study Arms (2)

Faculty doctors

Experienced endoscopists (\> 6000 cases). no intervention

Other: No intervention

Trainees

Doctors on fellowship who are inexperienced endoscopists (\< 4 months of endoscopy training) no intervention

Other: No intervention

Interventions

No interventionOTHER

retrospective data review

Faculty doctorsTrainees

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From May to July 2013, all the biopsy specimens from diagnostic esophagogastroduodenoscopy will be collected and analyzed in a single teaching hospital of Korea.

You may qualify if:

  • Diagnostic EGD including screening endoscopy for health check-up or endoscopic examinations for the symptomatic patients to make a diagnosis.

You may not qualify if:

  • Specimens from therapeutic procedures, such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

Chuncheon, Gangwon-do, 200-704, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Chang Seok Bang, MD

    Department of Internal Medicine, Hallym University College of Medicine, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterology, Doctor

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

KR(1)