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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03453580
Other study ID # MSCT GRADING
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 25, 2018
Est. completion date October 30, 2019

Study information

Verified date February 2018
Source Assiut University
Contact Mostafa Hashem Mahmoud, professor
Phone 01000684012
Email hashemradiol@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
multislice computed tomography portography
imaging modality

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Bajaj JS. Review article: potential mechanisms of action of rifaximin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther. 2016 Jan;43 Suppl 1:11-26. doi: 10.1111/apt.13435. Review. — View Citation

Biecker E. Gastrointestinal Bleeding in Cirrhotic Patients with Portal Hypertension. ISRN Hepatol. 2013 Jul 22;2013:541836. doi: 10.1155/2013/541836. eCollection 2013. Review. — View Citation

Chu Q, Li Z, Zhang SM, Hu DY, Xiao M. Relationship between encephalopathy and portal vein-vena cava shunt: value of computed tomography during arterial portography. World J Gastroenterol. 2004 Jul 1;10(13):1939-42. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Grading of liver cirrhosis 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
15 min
Secondary prediction of esophageal varices and hepatic encephalopathy measuring diameters of main portal vein,left gastric, splenic, intra hepatic right and left portal vein. 20 min