Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044536
• Other study ID #: BCS-2
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2014

Study information

• Verified date: October 2018
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1208
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasm

Intervention

Other:
• No intervention
retrospective data review

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distribution of the biopsied lesion	The distribution of the histologic and endoscopic diagnosis for total biopsied lesion will be analyzed.	During 3 months (retrospective endoscopy data review)
Primary	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	Neoplastic lesion detection rate	Neoplasm detection rates of diagnostic upper endoscopic biopsy between trainees and faculty doctors will be compared statistically.	During 3 months (retrospetive endoscopy data review)