- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024621
Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
July 16, 2012 updated by: Yanqing Li, Shandong University
Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer.
However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions.
Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract.
Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy.
This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Department of Gastroenterology, Qilu Hospital, Shandong University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 40 years old ≤ age < 80 years old
- Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
- Able to give informed consent.
Exclusion Criteria:
- Esophageal, gastric or duodenal cancer or other malignancy
- Known GIM or intraepithelial neoplasia in upper GI tract
- Scheduled for endoscopic therapy
- History of upper GI tract surgery
- Reflux esophagitis or acute gastritis or peptic ulcers
- Acute upper gastrointestinal bleeding
- Coagulopathy or bleeding disorders
- Allergy to fluorescein sodium
- Pregnant or breast-feeding (for females)
- Impaired renal function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
confocal laser endomicroscopy
|
Pentax EC3870K, Tokyo, Japan
Other Names:
|
Active Comparator: 2
standard endoscopy
|
Pentax EG-2931 gastroscope
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the diagnostic yield of gastric intestinal metaplasia
Time Frame: Seven months
|
Seven months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the biopsy number needed in each group
Time Frame: Seven months
|
Seven months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 2, 2009
First Posted (Estimate)
December 3, 2009
Study Record Updates
Last Update Posted (Estimate)
July 17, 2012
Last Update Submitted That Met QC Criteria
July 16, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009SDU-QILU-G06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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