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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)

50 Years
Not Enrolling
Gastric Intestinal Metaplasia

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Trial Information

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)

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.

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.

4. 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.

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

Exclusion Criteria:

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

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Diagnostic yield

Outcome Description:

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.

Outcome Time Frame:

On histopathologic diagnosis, usually 1-2 days after endoscopy

Safety Issue:


Principal Investigator

Khay Guan Yeoh, MBBS; M Med

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Health System


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

August 2007

Completion Date:

October 2010

Related Keywords:

  • Gastric Intestinal Metaplasia
  • intestinal metaplasia, gastric cancer
  • Neoplasms
  • Metaplasia
  • Gastritis, Atrophic