We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672708
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, 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

Condition or disease Intervention/treatment Phase
Gastric Intestinal Metaplasia Diagnostic Test: Cresyl violet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Actual Study Start Date : September 16, 2018
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : January 2, 2019

Arm Intervention/treatment
Cresyl violet 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




Primary Outcome Measures :
  1. feasibility of CV for identifying GIM [ Time Frame: 1 month ]
    ratio of pCLE failure to visualize the cellular and subcellular structures

  2. feasibility of CV for identifying GIM [ Time Frame: 1 month ]
    ratio of pCLE failure to recognize lesions and their immediate characterization

  3. newly pCLE criteria with CV application for GIM [ Time Frame: 1 month ]
    ratio of diagnostic agreement between pCLE using CV and histopathological results

  4. newly pCLE criteria with CV application for GIM [ Time Frame: 1 month ]
    number of diagnostic agreement between pCLE with CV application and histopathological results



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672708


Locations
Layout table for location information
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Yanqing Li, vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT03672708    
Other Study ID Numbers: 2018SDU-QILU-06
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Metaplasia
Pathologic Processes