Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment

October 7, 2018 updated by: Mahmoud Abdelhamed, Assiut University

Laoboratory and Ultrasonographic Changes After Endoscopic Varisceal Treatment

laboratory and ultrasongraphicc changes after endoscopical varices treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt, 171516
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with liver cirrhosis and portal hyprtension with esophagel varisces

Description

Inclusion Criteria:

  • patients with liver cirrhosis and portal hyprtension with esophagel varisces

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes
Device: biannual ultrasonography
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in liver function tests
Time Frame: 6 months

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
Time Frame: 6 months
{ 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2018

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

August 27, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (ACTUAL)

September 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • laucaevt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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