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

Gastric Intestinal Metaplasia Clinical Trial

Official title:

Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672708
• Other study ID #: 2018SDU-QILU-06
• Status: Completed
• Phase: N/A
• Start date: September 16, 2018
• Est. completion date: January 2, 2019

Study information

• Verified date: September 2018
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2, 2019
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Metaplasia

Intervention

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

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of CV for identifying GIM	ratio of pCLE failure to visualize the cellular and subcellular structures	1 month
Primary	feasibility of CV for identifying GIM	ratio of pCLE failure to recognize lesions and their immediate characterization	1 month
Primary	newly pCLE criteria with CV application for GIM	ratio of diagnostic agreement between pCLE using CV and histopathological results	1 month
Primary	newly pCLE criteria with CV application for GIM	number of diagnostic agreement between pCLE with CV application and histopathological results	1 month