A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The percentage of cancer cells in biopsy samples
Study Overview
Brief Summary
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells in biopsy samples.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age, between 20 and 80
- •Initial-onset gastric cancer which would be treated with surgery
Exclusion Criteria
- •Previous subtotal gastrectomy
- •Pregnancy or breast milk feeding
- •Active infection
- •Significant cardiopulmonary disease
- •Active hepatitis or severe hepatic dysfunction
- •Severe renal dysfunction
- •Severe bone marrow dysfunction
- •Severe neurologic or psychotic disorder
Arms & Interventions
Probe-based confocal laser endomicroscopy
Intervention: Probe-based confocal laser endomicroscopy (Procedure)
White light endoscopy
Intervention: White light endoscopy (Procedure)
Outcomes
Primary Outcomes
The percentage of cancer cells in biopsy samples
Time Frame: After 3 days from the end of the endoscopic submucosal dissection
The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy
Secondary Outcomes
No secondary outcomes reported