Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial
i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.
ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.
iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.
Study Overview
Status
Detailed Description
Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.
Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bankstown, Australia
- the University of New South Wales, Bankstown-Lidcombe Hospital
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Hongkong
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Hongkong, Hongkong, China
- the Prince of Wales Hospital, Chinese University of Hong Kong
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Shandong
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Jinan, Shandong, China, 20012
- Qilu Hospital, Shandong University
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Singapore, Singapore
- National University Hospital, National University of Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or Female aged 18-80
- Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis
Exclusion Criteria:
- Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
- Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
- Inability to provide informed consent and other situations that could interfere with the examination protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: CLE-TB
Confocal laser endomicroscopy with Targeted Biopsy
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Confocal laser endomicroscopy with Targeted Biopsy
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EXPERIMENTAL: WLE-SB
Standard White-light endoscopy with Standard Biopsy
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Standard White-light endoscopy with Standard Biopsy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of participant with gastric IM/IN/CA
Time Frame: 1 year
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To determine whether CLE with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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number of biopsies needed per patient
Time Frame: 1 year
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To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/CA without the loss of corresponding diagnostic yield.
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1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120621
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