Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intestinal Metaplasia

Intervention / Treatment
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* Device: Endomicroscope
* Device: Standard endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>confocal laser endomicroscopy | Device: Endomicroscope<br>* Pentax EC3870K, Tokyo, Japan<br>* Other names: Pentax EC3870K endomicroscope;|
| Active Comparator: 2<br>standard endoscopy | Device: Standard endoscopy<br>* Pentax EG-2931 gastroscope<br>* Other names: Pentax EC2931 gastroscope (Pentax, Tokyo, Japan);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diagnostic yield of gastric intestinal metaplasia |  | Seven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the biopsy number needed in each group |  | Seven months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric intestinal metaplasia, Confocal laser endomicroscopy