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Completed

NCT Number: NCT02044536

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

retrospective data review

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2014
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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