CClinicalTrials.gg
Status unknownNCT03453580Updated Jun 27, 2018

CT Portography in Grading of Liver Cirrhosis

An observational study in CT Portography Grading of Liver Cirrhosis, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • CT Portography Grading of Liver Cirrhosis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

liver cirrhosis

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Radiationmultislice computed tomography portography

    imaging modality

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 15 min

Secondary outcomes

  1. prediction of esophageal varices and hepatic encephalopathy

    measuring diameters of main portal vein,left gastric, splenic, intra hepatic right and left portal vein.

    Time frame: 20 min

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Biecker E. Gastrointestinal Bleeding in Cirrhotic Patients with Portal Hypertension. ISRN Hepatol. 2013 Jul 22;2013:541836. doi: 10.1155/2013/541836. eCollection 2013. PubMed 27335828 ↗
  • 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. PubMed 26618922 ↗
  • 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. doi: 10.3748/wjg.v10.i13.1939. PubMed 15222041 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03453580
Lead sponsor
Assiut University
Responsible party
Doaa Hamza (principal investigator, Assiut University) — Principal investigator
First posted
Mar 5, 2018
Start date
Sep 25, 2018 (estimated)
Primary completion
Sep 30, 2019 (estimated)
Completion
Oct 30, 2019 (estimated)
Last update
Jun 27, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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