Back to resultsRole of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
Primary Purpose
Undifferentiated Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France
white light endoscopy (WLE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Undifferentiated Gastric Cancer focused on measuring confocal laser endomicroscopy, undifferentiated gastric cancer, target biopsy
Eligibility Criteria
Inclusion Criteria:
A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery
Exclusion Criteria:
A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding
Sites / Locations
- Yonsei university of medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pCLE group
WLE group
Arm Description
The intervention group
The control group
Outcomes
Primary Outcome Measures
The percentage of cancer cells in biopsy samples
The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Secondary Outcome Measures
The expression ratio of tumor marker in biopsy samples
The expression ratio of tumor marker in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02799420
Brief Title
Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
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. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undifferentiated Gastric Cancer
Keywords
confocal laser endomicroscopy, undifferentiated gastric cancer, target biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pCLE group
Arm Type
Experimental
Arm Description
The intervention group
Arm Title
WLE group
Arm Type
Active Comparator
Arm Description
The control group
Intervention Type
Device
Intervention Name(s)
GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France
Intervention Description
The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.
Intervention Type
Device
Intervention Name(s)
white light endoscopy (WLE)
Intervention Description
The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy
Primary Outcome Measure Information:
Title
The percentage of cancer cells in biopsy samples
Description
The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
The expression ratio of tumor marker in biopsy samples
Description
The expression ratio of tumor marker in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy
Time Frame
Day 3
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:
A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery
Exclusion Criteria:
A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding
Facility Information:
Facility Name
Yonsei university of medical center
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data
Learn more about this trial
Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
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