Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia

Shandong University48 enrolled

Overview

Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastric Intestinal Metaplasia

Interventions

Cresyl violetDIAGNOSTIC_TEST

cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above * patients with H. pylori infection, or known GIM or atrophic gastritis Exclusion Criteria: * patients with a history of GI surgery * advanced gastric carcinoma or any other malignancy in the GI tract * acute upper GI bleeding * patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function * patients refused to provide informed consent

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

feasibility of CV for identifying GIM

ratio of pCLE failure to visualize the cellular and subcellular structures

Time frame: 1 month

feasibility of CV for identifying GIM

ratio of pCLE failure to recognize lesions and their immediate characterization

Time frame: 1 month

newly pCLE criteria with CV application for GIM

ratio of diagnostic agreement between pCLE using CV and histopathological results

Time frame: 1 month

newly pCLE criteria with CV application for GIM

number of diagnostic agreement between pCLE with CV application and histopathological results

Time frame: 1 month

Data from ClinicalTrials.gov

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