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Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

NCT01688687 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2012-09-20

No results posted yet for this study

Summary

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.

Conditions

  • Early Gastric Cancer
  • Gastric Dysplasia

Interventions

PROCEDURE

Endoscopic submucosal dissection

Sponsors & Collaborators

  • Soonchunhyang University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688687 on ClinicalTrials.gov