An observational study in Early Gastric Cancer and Gastric Dysplasia, sponsored by Soonchunhyang University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-09-20.
Sponsored by Soonchunhyang University Hospital · Observational
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 63 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Soonchunhyang University Hospital is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
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Consecutive patients referred to a tertiary medical center for endoscopic resection of gastric superficial lesions.
Exclusion Criteria:
Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion.
Procedure: Endoscopic submucosal dissection
The accuracy of pCLE compared to conventional forceps biopsy
The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference
Time frame: in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.
Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.
Time frame: 1-3 months after endoscopic resection and final histopathological analysis
Off-line pCLE interobserver agreement
Time frame: 1-3 months after endoscopic resection and final histopathological analysis
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Soonchunhyang University Hospital