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

Not Applicable

Completed

• Conditions: Gastric Intestinal Metaplasia
• Interventions: Diagnostic Test: Cresyl violet

• Registration Number: NCT03672708
• Lead Sponsor: Shandong University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-03
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2018-09-16
• Primary Completion: 2018-10-26
• Study Completion: 2019-01-02
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cresyl violet	Cresyl violet	-

Primary Outcome Measures

Name	Time	Method
newly pCLE criteria with CV application for GIM	1 month	number of diagnostic agreement between pCLE with CV application and histopathological results
feasibility of CV for identifying GIM	1 month	ratio of pCLE failure to recognize lesions and their immediate characterization

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China