Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

Study Overview
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Brief Summary
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Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of real time in-vivo pCLE diagnosis with that of blinded off-line pCLE diagnosis, and off-line interobserver agreement.

Official Title
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The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias

Conditions
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Early Gastric Cancer, Gastric Dysplasia

Intervention / Treatment
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* Procedure: Endoscopic submucosal dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection. Exclusion Criteria: Patients with uncorrectable coagulopathy, liver cirrhosis, acute gastrointestinal bleeding, pregnancy, breast feeding, documented allergy to fluorescein, patients with lesions that were deemed unsuitable for endoscopic resection, and patients without documented conventional biopsy results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Superficial gastric neoplasia<br>Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion. | Procedure: Endoscopic submucosal dissection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of pCLE compared to conventional forceps biopsy | The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference | in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of real time in-vivo pCLE diagnosis with that of blinded off-line pCLE diagnosis. |  | 1-3 months after endoscopic resection and final histopathological analysis | 
| Off-line pCLE interobserver agreement |  | 1-3 months after endoscopic resection and final histopathological analysis |