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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04388150
Other study ID # 0201288
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2019
Est. completion date March 1, 2021

Study information

Verified date March 2022
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

the study aims to evaluate the role of similar technology of Narrow Band Imaging VIST video intelligent staining technology in the diagnosis of Gastric Antral Vascular ectasia in cirrhotic patients


Description:

VIST (Video intelligent staining technology) is used to the diagnosis of GAVE as the form of ectatic vessels in the antrum in instead of erosions in the antrum by White light endoscopy which can mislead the diagnosis to Portal hypertension gastropathy. Targeted biopsies are taken and examined histopathologically in order to see if matching with VIST view. In addition, CD61 is used to highlight the diagnosis for more confirmation. CD61 is an immunohistochemistry platelets marker.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with mucosal vascular lesions at the gastric antrum suspicious of GAVE of a linear striped form or a diffuse punctate form upon conventional WLE Exclusion Criteria: - Connective tissue disorders like systemic sclerosis. - Chronic kidney disease. - Recent use of proton pump inhibitors in the last 14 days. - History of gastric surgery or gastric cancer. - Pernicious anemia. - Recent history of non-steroidal anti-inflammatory drugs intake

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Upper gastrointestinal endoscopy and biopsy
Gastroscope with technology of VIST video intelligent staining technology for taking biopsies

Locations

Country Name City State
Egypt Internal Medicine, Hepatology Unit. Faculty of Medicine, Alexandria University Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of Narrow Band Spectrum endoscopy for the diagnosis of Gastric antral vascular ectasia in cirrhotic patients It is done by the new technology of VIST which is similar to Narrow Band Imaging in the diagnosis of Gastric antral vascular ectasia in cirrhotic patients that were misdiagnosed before as portal hypertension gastropathy it is estimated to be 12 months
See also
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Recruiting NCT06306963 - Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Recruiting NCT05690750 - Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
Recruiting NCT03525366 - Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)