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Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

NCT01642797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2012-07-18

No results posted yet for this study

Summary

i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.

ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.

iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.

Conditions

  • Gastric Intestinal Metaplasia
  • Gastric Intraepithelial Neoplasia
  • Gastric Carcinoma

Interventions

DEVICE

Confocal laser endomicroscopy (Pentax, EG3870K)

Confocal laser endomicroscopy with Targeted Biopsy

DEVICE

Standard White-light endoscopy (Pentax, 90i)

Standard White-light endoscopy with Standard Biopsy

Sponsors & Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

    collaborator OTHER

  • National University Hospital, Singapore

    collaborator OTHER

  • The University of New South Wales

    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
2012-08-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • Australia
  • China
  • Singapore

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 NCT01642797 on ClinicalTrials.gov