pCLEThe Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias
Procedure Data
Collected from today forward - ProspectiveDigestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 1, 2012
Actual date on which the first participant was enrolled.Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and off-line interobserver agreement.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.63 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Soonchunhyang University Seoul Hospital
Seoul, South KoreaOpen Soonchunhyang University Seoul Hospital in Google Maps