NCT04388150

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

May 11, 2020

Last Update Submit

March 17, 2022

Conditions

Keywords

Narrow Band

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Gastroscope with technology of VIST video intelligent staining technology for taking biopsies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes all cirrhotic patients undergoing Upper gastrointestinal endoscopy and they have antral erosions by endoscopy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine, Hepatology Unit. Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Biospecimen

Retention: NONE RETAINED

biopsies

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Interventions

Endoscopy, Digestive SystemBiopsy

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesAngiodysplasiaVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingInvestigative Techniques

Study Officials

  • Randa Salah Eldin Abdelmoneim, Master

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Internal Medicine Department

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

November 11, 2019

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations