Clinical trial NCT01384201: Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Intestinal Metaplasia
Keywords: intestinal metaplasia, gastric cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese, above 50 years old, at high risk of gastric cancer

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.

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.

Primary outcomes:
measure: Diagnostic yield
timeFrame: On histopathologic diagnosis, usually 1-2 days after endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Health System
name: Khay Guan Yeoh, MBBS; M Med
role: PRINCIPAL_INVESTIGATOR
References: