Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02189226
NCT02189226
Completed
Not Applicable

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

Yonsei University1 site in 1 country101 target enrollmentNovember 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsEarly Gastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Gastric Cancer
Sponsor
Yonsei University
Enrollment
101
Locations
1
Primary Endpoint
Complete resection rate
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
January 20, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Complete resection rate

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor SurgeryPancreatic CancerDiagnosisPancreatoduodenectomyDistal Pancreatectomy
NCT06289803Fudan University200
Recruiting
Not Applicable
Probe-based confocal laser endomicroscopy(pCLE) under the direct view of cholangioscopy for diagnosis of biliary strictureBiliary stricture
JPRN-jRCTs031230238Tanisaka Yuki3
Completed
Not Applicable
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.Pleural Carcinomatosis
NCT03805971University of Liege65
Unknown
Not Applicable
Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal PolypsColorectal Polyps
NCT03620695Shandong University60
Unknown
Not Applicable
Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic SurgeryHepatocarcinomaHepatic MetastasisHepatic Tumor
NCT03718078Mauna Kea Technologies40