CT Portography Grading of Liver CirrhosisNCT03453580
CT Portography in Grading of Liver Cirrhosis
An observational study of CT Portography Grading of Liver Cirrhosis, run by Assiut University.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CT Portography Grading of Liver Cirrhosis
- What is being tested?
- multislice computed tomography portography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2018to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: liver cirrhosis
Who may be able to join
- Patients with cirrhosis and\or portal hypertension diagnosed by; laboratory or radiological parameters.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Multi Slice Computed Tomography Portography in Grading of Liver Cirrhosis
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
- Being tested
- multislice computed tomography portography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multislice computed tomography portographyRadiation
imaging modality
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start25 Sep 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CT Portography Grading of Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Hamza, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453580
- Sponsor's protocol ID
- MSCT GRADING
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27335828Bajaj 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 26618922Chu 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multi Slice Computed Tomography Portography in Grading of Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03453580
- Acronym / sponsor ID
- MSCT GRADING
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Sep 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- liver cirrhosis
Key inclusion criteria (1 listed)
- Patients with cirrhosis and\or portal hypertension diagnosed by; laboratory or radiological parameters.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multislice computed tomography portographyimaging modality | Radiation | – |
Primary outcome
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
1 secondary outcome
prediction of esophageal varices and hepatic encephalopathy
Time frame: 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Results publication: PubMed 27335828Biecker E. Gastrointestinal Bleeding in Cirrhotic Patients with Portal Hypertension. ISRN Hepatol. 2013 Jul 22;2013:541836. doi: 10.1155/2013/541836. eCollection 2013.
- Results publication: PubMed 26618922Bajaj 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.
- Results publication: PubMed 15222041Chu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of CT Portography Grading of Liver Cirrhosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Hashem Mahmoud, professor (01000684012, hashemradiol@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of liver cirrhosis (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453580, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.