NCT06089785

Brief Summary

  1. 1.evaluation of degree of spleen stiffness in liver cell failure patient by elastography.
  2. 2.correlation of degree of spleen stiffness and patient outcome

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress62%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

September 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3.2 years

First QC Date

September 29, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of splenic stiffness in liver cell failure patients: role of elastography

    1. evaluation of degree of spleen stiffness in liver cell failure patient by elastography. 2. correlation of degree of spleen stiffness and patient outcome

    4 years

Study Arms (1)

patients with liver cell failure

patients with liver cell failure and any complications

Device: elastography

Interventions

evaluation of degree of spleen stiffness in liver cell failure patient by elastography.

patients with liver cell failure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

any patient has any clinical picture for liver cell failure

You may qualify if:

  • Age above 18 years. 2-patients with liver cell failure (hepatic encephalopathy, hematemesis, ascites, hepatocellular carcinoma) 3- patient height , Weight

You may not qualify if:

  • patients who refuse to contribute in this study. 2- Age below 18 years. 3-pregnancy and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • Reiberger T. The Value of Liver and Spleen Stiffness for Evaluation of Portal Hypertension in Compensated Cirrhosis. Hepatol Commun. 2022 May;6(5):950-964. doi: 10.1002/hep4.1855. Epub 2021 Dec 14.

  • Yiyi M, Xiaoqin Q, Lei Z. Spleen Stiffness on Magnetic Resonance Elastography for the Detection of Portal Hypertension: A Systematic Review and Meta-Analysis. Iran J Public Health. 2022 Sep;51(9):1925-1935. doi: 10.18502/ijph.v51i9.10548.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples not dependent on DNA of the patients

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 18, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations