Efficacy of Narrow Band Spectrum Endoscopy for the Diagno... | NCT04388150

Studies
Efficacy of Narrow Band Spectrum Endoscopy for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis

NCT04388150

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Mar 21, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Gastric Antral Vascular Ectasia

Interventions

Upper gastrointestinal endoscopy and biopsy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

May 11, 2020

First Submission Date that Met QC Criteria

May 11, 2020

First Posted Date

May 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2022

Last Update Posted Date

Mar 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Randa Salah, Assistant lecturer, Internal Medicine Department, Alexandria UniversityPrincipal Investigator

Lead Sponsor

Alexandria UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upper gastrointestinal endoscopy and biopsy	Diagnostic Test	Gastroscope with technology of VIST video intelligent staining technology for taking biopsies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randa Salah Eldin Abdelmoneim, Master	Alexandria University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internal Medicine, Hepatology Unit. Faculty of Medicine, Alexandria University		Alexandria			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020252	Gastric Antral Vascular Ectasia

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D016888	Angiodysplasia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016145	Endoscopy, Digestive System
D001706	Biopsy

Ancestor Terms

ID	Term
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided