NCT03269786

Brief Summary

laboratory and ultrasongraphicc changes after endoscopical varices treatment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

August 27, 2017

Last Update Submit

October 7, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in liver function tests

    Liver function tests (ALT, AST, bilirubin,Albumin,Cbc,Prothrombin time,INR ) level (expected to be lower after endoscopic varisceal treatment (ex

    6 months

  • Ultrasonographic changes

    { portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.(expected to be chnged after endoscopic varisceal treatment

    6 months

Study Arms (1)

cirrhotic patients with esophagel varisces

Endoscopic band ligation or injection scelerotheraby will be done for all patients

Diagnostic Test: Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)Device: biannual ultrasonography

Interventions

Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes

cirrhotic patients with esophagel varisces

portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.will be assessed after endoscopic varisceal treatment by using biannual ultrasonography for 6 monthes

cirrhotic patients with esophagel varisces

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients with liver cirrhosis and portal hyprtension with esophagel varisces

You may qualify if:

  • patients with liver cirrhosis and portal hyprtension with esophagel varisces

You may not qualify if:

  • \. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with hepato cellular carcinoma and portal vein thrombosis 4. Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Liver Function Tests

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

salwa el gendi, professor doctor

CONTACT

hanan sharaf, assistant professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 27, 2017

First Posted

September 1, 2017

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations