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

Not Applicable

Completed

• Conditions: Early Gastric Cancer
• Interventions: Device: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)

• Registration Number: NCT02189226
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Primary Completion: 2015-01-20
• Study Completion: 2015-01-20
• Status Verified: 2015-12
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probe-based confocal laser endomicroscopy (pCLE) group	Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)	-
chromoendoscopy (CE) group	Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)	-

Primary Outcome Measures

Name	Time	Method
Complete resection rate	One week after ESD	Complete resection is defined as en bloc resection with negative horizontal, vertical margin and distance from marking dot to histologic margin will be measured.

Secondary Outcome Measures

Name	Time	Method
vertical cut end-positive	Within the first 30 days after ESD
procedure time	1 day
Horizontal cut end-positive	Within the first 30 days after ESD
adverse event	Within the first 30 days after ESD

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of