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Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial

Sponsor
Shandong University (Other)
Overall Status
Completed
CT.gov ID
NCT01024621
Collaborator
(none)
168
Enrollment
1
Location
2
Arms
8
Duration (Months)
21.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Condition or Disease Intervention/Treatment Phase
  • Device: Endomicroscope
  • Device: Standard endoscopy
 N/A

Detailed Description

Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

confocal laser endomicroscopy

Device: Endomicroscope
Pentax EC3870K, Tokyo, Japan
Other Names:
  • Pentax EC3870K endomicroscope

    		•
    Active Comparator: 2

    standard endoscopy

    Device: Standard endoscopy
    Pentax EG-2931 gastroscope
    Other Names:
  • Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the diagnostic yield of gastric intestinal metaplasia [Seven months]

    Secondary Outcome Measures

    1. the biopsy number needed in each group [Seven months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 40 years old ≤ age < 80 years old

    • Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia

    • Able to give informed consent.

    Exclusion Criteria:

    • Esophageal, gastric or duodenal cancer or other malignancy

    • Known GIM or intraepithelial neoplasia in upper GI tract

    • Scheduled for endoscopic therapy

    • History of upper GI tract surgery

    • Reflux esophagitis or acute gastritis or peptic ulcers

    • Acute upper gastrointestinal bleeding

    • Coagulopathy or bleeding disorders

    • Allergy to fluorescein sodium

    • Pregnant or breast-feeding (for females)

    • Impaired renal function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Shandong University

    Investigators

    • Study Director: Yanqing Li, PhD. MD., Department of Gastroenterology, Qilu Hospital, Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanqing Li, Chief of the Department of Gastroenterolgoy, Qilu Hospital, Shandong University
    ClinicalTrials.gov Identifier:
    NCT01024621
    Other Study ID Numbers:
    • 2009SDU-QILU-G06
    First Posted:
    Dec 3, 2009
    Last Update Posted:
    Jul 17, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Yanqing Li, Chief of the Department of Gastroenterolgoy, Qilu Hospital, Shandong University
    gastric intestinal metaplasia
    Confocal laser endomicroscopy
    Additional relevant MeSH terms:
    Metaplasia

    Study Results

    No Results Posted as of Jul 17, 2012