Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection

Yonsei University

Status

Completed

Conditions

Early Gastric Cancer

Treatments

Device: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)

Study type

Interventional

Funder types

Other

Identifiers

NCT02189226

1-2013-0009

Details and patient eligibility

About

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 cancer (EGC) with endoscopic submucosal dissection (ESD).

Enrollment

101 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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