Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia

NCT ID: NCT01384201

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-10-31

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.

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.

Conditions

Gastric Intestinal Metaplasia

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Confocal Laser Endomicroscopy

OGD by Confocal Endomicroscopy

No interventions assigned to this group

White light endoscopy

OGD by whitelight endoscopy

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

National University Health System, Singapore

Principal Investigators

Khay Guan Yeoh, MBBS; M Med

Role: PRINCIPAL_INVESTIGATOR

National University Health System

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NMRC/TCR/001/2007/CLE

Identifier Type: -

Identifier Source: org_study_id