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CT Portography in Grading of Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453580
Recruitment Status : Unknown
Verified February 2018 by Doaa Hamza, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Doaa Hamza, Assiut University

Study Description
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Brief Summary:
Esophageal variceal bleeding and hepatic encephalopathy are serious complications of hepatic cirrhosis, and they may lead to high mortality rate and severely threaten life quality of the patients

Condition or disease Intervention/treatment
CT Portography Grading of Liver Cirrhosis Radiation: multislice computed tomography portography

Detailed Description:

The occurrence and development of Esophageal variceal bleeding and hepatic encephalopathy are closely related with portal vein system diseases, such as collateral circulation of portal hypertension and portal vein thrombosis.

The prevention of Esophageal variceal bleeding and hepatic encephalopathy in hepatic cirrhosis has become a hot spot in clinical practice.

Three-dimensional reconstruction of images obtained by multi-slice spiral computed tomography portography (MSCTP) is clear, realistic, and accurate.

It can directly and quickly display all anatomical information of collateral portal vein system, and is recognized as a good method to display blood vessels

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Role of Multi Slice Computed Tomography Portography in Grading of Liver Cirrhosis
Estimated Study Start Date : September 25, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Radiation: multislice computed tomography portography
    imaging modality

Outcome Measures
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Primary Outcome Measures :
  1. Grading of liver cirrhosis [ Time Frame: 15 min ]

    Grade I: i)level 4-5 by portal development will achieved in intrahepatic portal vein imaging; ii) collateral circulation mainly open at esophageal gastric fundus vein, or one branch of para-umbilical vein or esophageal peripheral vein was open; iii) hepatic artery-portal vein fistula or portal vein embolus was not formed.

    Grade II: i)level 3-4 by portal development will achieved in intrahepatic portal vein imaging; ii) in addition to opening of collateral circulation at esophageal gastric fundus vein, 2-3 branches of para-umbilical vein or esophageal peripheral vein open; iii) some hepatic artery-portal vein fistula or portal vein embolus not observed.

    Grade lll: level 2-3 by portal development are achieved in intrahepatic portal vein imaging; ii) esophageal gastric fundus vein, para-umbilical vein or esophageal peripheral vein all open, iii) hepatic artery-portal vein fistula or portal vein embolus is formed.

    Then we will do correlation with child -pugh score



Secondary Outcome Measures :
  1. prediction of esophageal varices and hepatic encephalopathy [ Time Frame: 20 min ]
    measuring diameters of main portal vein,left gastric, splenic, intra hepatic right and left portal vein.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
liver cirrhosis
Criteria

Inclusion Criteria:

  • Patients with cirrhosis and\or portal hypertension diagnosed by; laboratory or radiological parameters.

Exclusion Criteria:

  • Patients with ligation, disconnection or shunting of esophageal varices. Patients with combined hepatic malignant tumor Patients with splenectomy. Patients with renal dysfunction or iodine allergy.
Contacts and Locations
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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): NCT03453580


Contacts
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Contact: Mostafa Hashem Mahmoud, professor 01000684012 hashemradiol@yahoo.com
Contact: Marwa Mohamed Samy Mohamed, lecturer 01025260404 marwasamy2014@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Publications of Results:

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Responsible Party: Doaa Hamza, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03453580    
Other Study ID Numbers: MSCT GRADING
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: February 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
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases