Back to resultsConfocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
Primary Purpose
Intestinal Metaplasia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endomicroscope
Standard endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Intestinal Metaplasia focused on measuring gastric intestinal metaplasia, Confocal laser endomicroscopy
Eligibility Criteria
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
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
confocal laser endomicroscopy
standard endoscopy
Outcomes
Primary Outcome Measures
the diagnostic yield of gastric intestinal metaplasia
Secondary Outcome Measures
the biopsy number needed in each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01024621
Brief Title
Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Metaplasia
Keywords
gastric intestinal metaplasia, Confocal laser endomicroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
confocal laser endomicroscopy
Arm Title
2
Arm Type
Active Comparator
Arm Description
standard endoscopy
Intervention Type
Device
Intervention Name(s)
Endomicroscope
Other Intervention Name(s)
Pentax EC3870K endomicroscope
Intervention Description
Pentax EC3870K, Tokyo, Japan
Intervention Type
Device
Intervention Name(s)
Standard endoscopy
Other Intervention Name(s)
Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)
Intervention Description
Pentax EG-2931 gastroscope
Primary Outcome Measure Information:
Title
the diagnostic yield of gastric intestinal metaplasia
Time Frame
Seven months
Secondary Outcome Measure Information:
Title
the biopsy number needed in each group
Time Frame
Seven months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD. MD.
Organizational Affiliation
Department of Gastroenterology, Qilu Hospital, Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Learn more about this trial
Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
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