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

May 10, 2019 updated by: Yanqing Li, Shandong University

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

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 Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yanqing Li, PhD,MD, Department of Gastroenterology,QiLu Hospital,Shandong University
  • Study Director: Zhen Li, PhD,MD, Department of Gastroenterology,QiLu Hospital,Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2018

Primary Completion (Actual)

October 26, 2018

Study Completion (Actual)

January 2, 2019

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018SDU-QILU-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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