PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

Study Overview
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Brief Summary
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Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.

Official Title
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Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial

Conditions
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Diagnostic Yield of Gastric Neoplasia

Intervention / Treatment
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* Device: pCLE-TB
* Device: virtual chromoendoscopy-TB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 80; patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia; agree to give written informed consent. Exclusion Criteria: Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia; Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pCLE-TB<br>Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma. | Device: pCLE-TB<br>* Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.<br>* Other names: probe-based confocal laser endomicroscopy with targeted biopsies;|
| Experimental: Virtual Chromoendoscopy -SB<br>Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions. | Device: virtual chromoendoscopy-TB<br>* Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.<br>* Other names: virtual chromoendoscopy with targeted biopsies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the biopsy number needed for diagnosis |  | 12 months |