Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection
Conditions
Early Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
probe-based confocal laser endomicroscopy (pCLE), early gastric cancer (EGC), endoscopic submucosal dissection (ESD), margin
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)
Type: Device
Overall Status
Recruiting
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 cancer (EGC) with endoscopic submucosal dissection (ESD).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Location
Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Ye hyun Park, MD - 82-2-2228-6661 - TWINKLEGIRL1@yuhs.ac
Start Date
November 2013
Completion Date
October 2014
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page