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R-CE-GCEP: Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT01384201
Collaborator
(none)
100
Enrollment
1
Location
38
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective randomised study investigating the use of chromoendoscopy and confocal laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of gastric cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective randomised study investigating the use of chromoendoscopy and confocal laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of gastric cancer. Patients are randomised to undergo upper endoscopy using either confocal laser endomicroscopy or standard whitelight endoscopy to investigate for gastric preneoplastic and neoplastic lesions.Results are compared to histopathologic diagnosis made on biopsies obtained during endoscopy.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Use of Confocal Endomicroscopy in Conjunction With Chromoendoscopy in the Detection of Gastric Preneoplastic Neoplasia and Neoplasia in a High-Risk Population (R-CE-GCEP)
    Study Start Date :
    Aug 1, 2007
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Confocal Laser Endomicroscopy

    OGD by Confocal Endomicroscopy
    White light endoscopy

    OGD by whitelight endoscopy

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic yield [On histopathologic diagnosis, usually 1-2 days after endoscopy]

      The diagnostic yield, number of tissue biopsies per patient and percentage of missed lesions for CLE arm will be obtained by analyzing as though only targeted tissue biopsies are taken (CLE-TB), meaning that tissue biopsy is considered to have been performed only if the endoscopist gave the CLE diagnosis of GIM, dysplasia or malignancy. If the CLE diagnosis is normal, targeted tissue biopsy will be analyzed as not having been taken, and the corresponding histology for that site is for documenting any misdiagnosis by CLE in this study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The subject is Chinese

    2. The subject is greater than 50 years of age

    3. The subject satisfies one or more of the following criteria:

    • has (had) a history of dyspepsia of at least 4 weeks or more. Dyspeptic symptoms include bloating, epigastric discomfort and early satiety

    • has a family history of gastric cancer

    • has a medical condition for which an OGD is indicated.

    1. The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.

    2. The subject must be willing and able to comply with scheduled visits and other study procedures

    Exclusion Criteria:

    1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.

    2. The subject with liver cirrhosis.

    3. The subject with previous total or partial gastrectomy.

    4. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy.

    5. The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.

    6. The subject is currently on anti-coagulant therapy such as warfarin. Patients on aspirin, ticlopidine and clopidogrel must undergo a one-week washout period before enroling in the study.

    7. The subject has a history of bronchial asthma, or a known allergy to fluorescein.

    8. The subject is unwilling or unable to provide signed informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National University Hospital Singapore Singapore

    Sponsors and Collaborators

    • National University Hospital, Singapore

    Investigators

    • Principal Investigator: Khay Guan Yeoh, MBBS; M Med, National University Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01384201
    Other Study ID Numbers:
    • NMRC/TCR/001/2007/CLE
    First Posted:
    Jun 28, 2011
    Last Update Posted:
    Jun 28, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    intestinal metaplasia, gastric cancer
    Additional relevant MeSH terms:
    Neoplasms
    Metaplasia

    Study Results

    No Results Posted as of Jun 28, 2011