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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Intestinal Metaplasia

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese, above 50 years old, at high risk of gastric cancer

Description

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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Confocal Laser Endomicroscopy; OGD by Confocal Endomicroscopy
White light endoscopy; OGD by whitelight endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	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.	On histopathologic diagnosis, usually 1-2 days after endoscopy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: intestinal metaplasia, gastric cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Metaplasia
• Other Study ID Numbers: NMRC/TCR/001/2007/CLE