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

Shandong University

Status: Completed

Conditions: Gastric Intestinal Metaplasia

Treatments: Diagnostic Test: Cresyl violet

Study type: Interventional

Funder types: Other

Identifiers

NCT03672708

2018SDU-QILU-06

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Cresyl violet

Other group

Treatment:

Diagnostic Test: Cresyl violet