Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy

Completed

• Conditions: Neoplasm
• Interventions: Other: No intervention

• Registration Number: NCT02044536
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1208

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Faculty doctors	No intervention	Experienced endoscopists (\> 6000 cases). no intervention
Trainees	No intervention	Doctors on fellowship who are inexperienced endoscopists (\< 4 months of endoscopy training) no intervention

Primary Outcome Measures

Name	Time	Method
Concordance rate of endoscopic diagnosis and histologic diagnosis	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of