Gastric Carcinoma Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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