Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy

October 23, 2018 updated by: Chang Seok Bang, Chuncheon Sacred Heart Hospital

Retrospective Study of Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The endoscopic examination is indicated in the diagnosis of variety of gastrointestinal diseases and screening for the neoplastic lesions. Especially, in Korea where the stomach cancer prevalent area, high-quality endoscopic examination is required not to overlook pathologic lesions. Endoscopic biopsy is the gold standard for the confirmation of endoscopic diagnosis. It is usually decided based on the abnormal morphology of the lesions or color change of the mucosa. Diagnostic accuracy is known to be improved by training or using optical techniques or chromoendoscopy. With the development of endoscopic imaging technologies such as narrow band imaging (NBI), confocal imaging or magnifying techniques, the diagnostic accuracy can be enhanced. However, inspection with conventional white light endoscopy is still the most prevalent and basic form of screening or surveillance endoscopy. Thus, detecting lesions by meticulous inspection and accurate approach by targeted biopsy are important for the diagnosis of pathologic lesions. However, the optimal number of biopsy and the detection rate of neoplastic lesions are not established. This study aimed at evaluating the current practice pattern and effect of training in conventional upper endoscopic biopsy.

Study Type

Observational

Enrollment (Actual)

1208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 200-704
        • Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Faculty doctors
Experienced endoscopists (> 6000 cases). no intervention
Other: No intervention
retrospective data review
Trainees
Doctors on fellowship who are inexperienced endoscopists (< 4 months of endoscopy training) no intervention
Other: No intervention
retrospective data review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate of endoscopic diagnosis and histologic diagnosis
Time Frame: During 3 months (retrospective endoscopy data review)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neoplastic lesion detection rate
Time Frame: During 3 months (retrospetive endoscopy data review)
Neoplasm detection rates of diagnostic upper endoscopic biopsy between trainees and faculty doctors will be compared statistically.
During 3 months (retrospetive endoscopy data review)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of the biopsied lesion
Time Frame: During 3 months (retrospective endoscopy data review)
The distribution of the histologic and endoscopic diagnosis for total biopsied lesion will be analyzed.
During 3 months (retrospective endoscopy data review)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Principal Investigator: Chang Seok Bang, MD, Department of Internal Medicine, Hallym University College of Medicine, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCS-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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