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

Shandong University

Status: Unknown

Conditions: Diagnostic Yield of Gastric Neoplasia

Treatments: Device: virtual chromoendoscopy-TB; Device: pCLE-TB

Study type: Interventional

Funder types: Other

Identifiers

NCT02515721

2015SDU-QILU-G06

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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242 participants in 2 patient groups

pCLE-TB

Experimental group

Description:

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.

Treatment:

Device: pCLE-TB

Virtual Chromoendoscopy -SB

Experimental group

Description:

Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.

Treatment:

Device: virtual chromoendoscopy-TB