Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy

Sponsor
Chuncheon Sacred Heart Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02044536
Collaborator
(none)
1,208
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Actual Enrollment :
1208 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Retrospective Study of Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. Distribution of the biopsied lesion [During 3 months (retrospective endoscopy data review)]

    The distribution of the histologic and endoscopic diagnosis for total biopsied lesion will be analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine Chuncheon Gangwon-do Korea, Republic of 200-704

Sponsors and Collaborators

  • Chuncheon Sacred Heart Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Seok Bang, Department of Gastroenterology, Doctor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT02044536
Other Study ID Numbers:
  • BCS-2
First Posted:
Jan 24, 2014
Last Update Posted:
Oct 25, 2018
Last Verified:
Oct 1, 2018
Keywords provided by Chang Seok Bang, Department of Gastroenterology, Doctor, Chuncheon Sacred Heart Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2018