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

Shandong University242 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

242

Conditions

Diagnostic Yield of Gastric Neoplasia

Interventions

pCLE-TBDEVICE

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.

virtual chromoendoscopy-TBDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Endoscopic unit of Qilu Hospital Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer

Time frame: 12 months

Secondary Outcomes

the biopsy number needed for diagnosis

Time frame: 12 months

Central Contacts

Li Yanqing, PhD, MD

CONTACT

053182169385 liyanqing@sdu.edu.cn

Li Zhen, PhD, MD

CONTACT

18560086106 lizhenh@hotmail.com

Data from ClinicalTrials.gov

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