Clinical trial NCT02044536: Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy
Official title: Retrospective Study of Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm
Keywords: biopsy
endoscopy
neoplasms
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 1208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Concordance rate of endoscopic diagnosis and histologic diagnosis
timeFrame: During 3 months (retrospective endoscopy data review)
Secondary outcomes:
measure: Neoplastic lesion detection rate
timeFrame: During 3 months (retrospetive endoscopy data review)
Other outcomes:
measure: Distribution of the biopsied lesion
timeFrame: During 3 months (retrospective endoscopy data review)
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
state: Gangwon-do
Study officials:
affiliation: Department of Internal Medicine, Hallym University College of Medicine, Korea
name: Chang Seok Bang, MD
role: PRINCIPAL_INVESTIGATOR
References: