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Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment

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ClinicalTrials.gov Identifier: NCT03269786
Recruitment Status : Not yet recruiting
First Posted : September 1, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mahmoud Abdelhamed, Assiut University

Brief Summary:
laboratory and ultrasongraphicc changes after endoscopical varices treatment

Condition or disease Intervention/treatment
Liver Cirrhosis Diagnostic Test: Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC) Device: biannual ultrasonography

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Laoboratory and Ultrasonographic Changes After Endoscopic Varisceal Treatment
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


  2. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with liver cirrhosis and portal hyprtension with esophagel varisces
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269786


Contacts
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Contact: salwa el gendi, professor doctor 01005766155 salwaelgendi@yahoo.com
Contact: hanan sharaf, assistant professor 01005035006 dr_hanansharaf@yahoo.com

Locations
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Egypt
Assiut University Recruiting
Assuit, Egypt, 171516
Contact: Salwa elgendi, Proessor doctor    01005766155    sawaelgendi@yahoo.com   
Contact: hanan sharaf, assI stand professor    01005035006    dr_hanansharaf@.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Mahmoud Abdelhamed, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03269786     History of Changes
Other Study ID Numbers: laucaevt
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs