Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia

NCT01384201 | Completed

• 1 other identifier: NMRC/TCR/001/2007/CLE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Intestinal Metaplasia

Keywords

intestinal metaplasia, gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Confocal Laser Endomicroscopy

OGD by Confocal Endomicroscopy

White light endoscopy

OGD by whitelight endoscopy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• The subject is Chinese
• The subject is greater than 50 years of age
• 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.
• 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.
• The subject must be willing and able to comply with scheduled visits and other study procedures

You may not qualify if:

• The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
• The subject with liver cirrhosis.
• The subject with previous total or partial gastrectomy.
• 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.
• 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.
• 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.
• The subject has a history of bronchial asthma, or a known allergy to fluorescein.
• The subject is unwilling or unable to provide signed informed consent.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Biospecimen

Retention: NONE RETAINED

Biopsies from the stomach

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Khay Guan Yeoh, MBBS; M Med

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: August 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

SG (1)