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

Not Applicable

• Conditions: Diagnostic Yield of Gastric Neoplasia
• Interventions: Device: virtual chromoendoscopy-TB; Device: pCLE-TB

• Registration Number: NCT02515721
• Lead Sponsor: Shandong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Study First Posted: 2015-08-05
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Chromoendoscopy -SB	virtual chromoendoscopy-TB	Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
pCLE-TB	pCLE-TB	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.

Primary Outcome Measures

Name	Time	Method
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer	12 months

Secondary Outcome Measures

Name	Time	Method
the biopsy number needed for diagnosis	12 months

Trial Locations

Locations (1)

Endoscopic unit of Qilu Hospital Shandong University; 🇨🇳 Jinan, Shandong, China