A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probe-based confocal laser endomicroscopy
White light endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Cancer
Eligibility Criteria
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
Sites / Locations
- Institutional Review Board in Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Probe-based confocal laser endomicroscopy
White light endoscopy
Arm Description
Outcomes
Primary Outcome Measures
The percentage of cancer cells in biopsy samples
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02089373
Brief Title
A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probe-based confocal laser endomicroscopy
Arm Type
Experimental
Arm Title
White light endoscopy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Probe-based confocal laser endomicroscopy
Intervention Description
In this arm1, an investigator observes a cancerous lesion using white light endoscopy. In addition, contrast dye for confocal laser endomicorscopy (fluorescein sodium 0.1mL/kg) is administered. Then, the cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy would be done 5 times at the most suspcious parts of the cancerous lesion.
Intervention Type
Procedure
Intervention Name(s)
White light endoscopy
Intervention Description
In this arm2, an invesigator observes a cancerous lesion using white light endoscopy. The biopsy would be done 5 times at the most suspicious parts of the cancerous lesion.
Primary Outcome Measure Information:
Title
The percentage of cancer cells in biopsy samples
Description
The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy
Time Frame
After 3 days from the end of the endoscopic submucosal dissection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institutional Review Board in Severance Hospital
City
Seodaemun-gu
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
We'll reach out to this number within 24 hrs