Back to resultsConfocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Primary Purpose
Gastric Intestinal Metaplasia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cresyl violet
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Intestinal Metaplasia
Eligibility 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
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cresyl violet
Arm Description
Outcomes
Primary Outcome Measures
feasibility of CV for identifying GIM
ratio of pCLE failure to visualize the cellular and subcellular structures
feasibility of CV for identifying GIM
ratio of pCLE failure to recognize lesions and their immediate characterization
newly pCLE criteria with CV application for GIM
ratio of diagnostic agreement between pCLE using CV and histopathological results
newly pCLE criteria with CV application for GIM
number of diagnostic agreement between pCLE with CV application and histopathological results
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03672708
Brief Title
Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Official Title
Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2018 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
January 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cresyl violet
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Cresyl violet
Intervention Description
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 Measure Information:
Title
feasibility of CV for identifying GIM
Description
ratio of pCLE failure to visualize the cellular and subcellular structures
Time Frame
1 month
Title
feasibility of CV for identifying GIM
Description
ratio of pCLE failure to recognize lesions and their immediate characterization
Time Frame
1 month
Title
newly pCLE criteria with CV application for GIM
Description
ratio of diagnostic agreement between pCLE using CV and histopathological results
Time Frame
1 month
Title
newly pCLE criteria with CV application for GIM
Description
number of diagnostic agreement between pCLE with CV application and histopathological results
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD,MD
Organizational Affiliation
Department of Gastroenterology,Qilu Hospital,shandong University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhen Li, PhD,MD
Organizational Affiliation
Department of Gastroenterology,Qilu Hospital,shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Learn more about this trial
Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia
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