A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Conditions
Gastric Cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Probe-based confocal laser endomicroscopy Type: Procedure
Name: White light endoscopy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Age, between 20 and 80

2. Initial-onset gastric cancer which would be treated with surgery

Exclusion Criteria:

1. Previous subtotal gastrectomy

2. Pregnancy or breast milk feeding

3. Active infection

4. Significant cardiopulmonary disease

5. Active hepatitis or severe hepatic dysfunction

6. Severe renal dysfunction

7. Severe bone marrow dysfunction

8. Severe neurologic or psychotic disorder
Location
Institutional Review Board in Severance Hospital
Seodaemun-gu, Seoul, Korea, Republic of
Status: Recruiting
Contact: Sang Kil Lee, MD - 82-2-2228-1996 - sklee@yuhs.ac
Start Date
March 2014
Completion Date
August 2015
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page