Status:
COMPLETED
Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection
Lead Sponsor:
Yonsei University
Conditions:
Early Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of early gastric canc...
Eligibility Criteria
Inclusion
- Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1) Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with ulcer, ≤ 3 cm 3) Differentiated minute (\<500 μm) submucosal invasive cancer, ≤ 3 cm 4) Undifferentiated mucosal cancer without ulcer, ≤ 2 cm
- Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC and treated by ESD
Exclusion
- Coagulopathy : International normalized ratio \[INR\] \> 1.5 or platelet count \<50,000 cell/cubic millimeter)
- Impaired renal function : Cr \> 1.2 mg/dL
- Pregnancy or breast-feeding
- Age \< 20 years
- Allergy to fluorescein dye
- Inability to provide informed consent
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT02189226
Start Date
November 1 2013
End Date
January 20 2015
Last Update
April 1 2019
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 120-752