Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia (R-CE-GCEP)
This study has been completed.
Sponsor:
National University Hospital, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01384201
First received: June 27, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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Purpose
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.
| Condition |
|---|
|
Gastric Intestinal Metaplasia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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) |
Resource links provided by NLM:
Further study details as provided by National University Hospital, Singapore:
Primary Outcome Measures:
- Diagnostic yield [ Time Frame: On histopathologic diagnosis, usually 1-2 days after endoscopy ] [ Designated as safety issue: No ]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.
Biospecimen Retention: None Retained
Biopsies from the stomach
| Enrollment: | 100 |
| Study Start Date: | August 2007 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Confocal Laser Endomicroscopy
OGD by Confocal Endomicroscopy
|
|
White light endoscopy
OGD by whitelight endoscopy
|
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Chinese, above 50 years old, at high risk of gastric cancer
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384201
Locations
| Singapore | |
| National University Hospital | |
| Singapore, Singapore | |
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
| Principal Investigator: | Khay Guan Yeoh, MBBS; M Med | National University Health System |
More Information
No publications provided
| Responsible Party: | Associate Professor Yeoh Khay Guan, National University Health System, Singapore |
| ClinicalTrials.gov Identifier: | NCT01384201 History of Changes |
| Other Study ID Numbers: | NMRC/TCR/001/2007/CLE |
| Study First Received: | June 27, 2011 |
| Last Updated: | June 27, 2011 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by National University Hospital, Singapore:
|
intestinal metaplasia, gastric cancer |
Additional relevant MeSH terms:
|
Neoplasms Metaplasia Gastritis, Atrophic Pathologic Processes Gastritis |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 16, 2013