- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672708
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
Conditions
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.
Sponsor
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.
Clinical Trials on Gastric Intestinal Metaplasia
-
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-
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The University of Hong KongCompletedIntestinal Metaplasia | Gastric DysplasiaHong Kong
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