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PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

NCT02515721 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2015-08-05

No results posted yet for this study

Summary

Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.

Conditions

  • Diagnostic Yield of Gastric Neoplasia

Interventions

DEVICE

pCLE-TB

Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.

DEVICE

virtual chromoendoscopy-TB

Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-08-31

Countries

  • China

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 NCT02515721 on ClinicalTrials.gov