NCT04774601

Brief Summary

Chronic liver disease is a significant health issue among children and it can result in fibrosis, cirrhosis and liver failure. Since the prognosis and monitoring of these diseases are different from each other,, Conventional ultrasonography is preferred for the investigation of chronic liver diseases in children, as it is non-invasive, cheap, feasible and available. Elastography, an ultrasonographic non-invasive procedure that measures tissue stiffness.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Status
unknown

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

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

February 25, 2021

Last Update Submit

March 26, 2021

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Comparison the results of ultrasound elastography in chronic liver disease in children with histopathlogical findings .

    evaluate liver stiffness as a marker of severity and duration of the underlying chronic liver disease in children to achieve early diagnosis and benefit from treatment .

    Baseline

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients males and /or females from ( 0 to 18 years ) have clinical or laboratory or histopathological evidence of chronic liver disease und had undergone liver biopsy.

You may qualify if:

  • all patients referred to the radiology department over the estimated period of the study. 2 - males and /or females from ( 0 to 18 years ) 3 - have clinical or laboratory or histopathological evidence of chronic liver disease 4 - had undergone liver biopsy.

You may not qualify if:

  • \- Patients males and or females older than 18 years
  • \- Patients who hadn't undergone liver biopsy previously
  • \- Patients with acute liver disease
  • \- Patients with human immune- deficiency virus (HIV) co infection.
  • \- patients with pacemaker (PM) or implantable cardioverter defibrillator (ICD) devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sonmez S, Bosat M, Yurtseven N, Yurtseven E. The role of elastography in the assessment of chronic liver disease in children. Afr Health Sci. 2019 Sep;19(3):2806-2811. doi: 10.4314/ahs.v19i3.57.

    PMID: 32127854BACKGROUND

Study Officials

  • Prof.Mostafa Thabet, Professor

    Assiut University

    STUDY CHAIR

  • Prof.Mohamed koriem, Assistant professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mostafa Khalf, Resident

CONTACT

01550789590mostafakhalf@icloud.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

June 1, 2022

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

March 29, 2021

Record last verified: 2021-03