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Magnetic Resonance Technics for the Assessment of Liver Function Before and After TIPS

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ClinicalTrials.gov Identifier: NCT03933891
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
luo xuefeng, West China Hospital

Brief Summary:

Portal hypertension is the end-stage fatal complications of liver cirrhosis. Decompensated cirrhosis patients can pass through transjugular intrahepatic portosystemic shunt to effectively prevent bleeding and refractory ascites. However, the occurrence of hepatic encephalopathy and liver function failure, infection, bleeding again are main lethality postoperative complications after TIPS. The accurate TIPS shunt is necessary to reduce the incidence of complications and improve the patients' survival rate and survival quality. Hepatic venous pressure gradient (HVPG) is standard to evaluate TIPS preoperative and postoperative hemodynamic change and is also the most important the predictors of decompensation and varicose vein bleeding of liver cirrhosis. Whether there is a kind of noninvasive monitoring method can guide TIPS accurate shunt and evaluate the prognosis of patients.

Magnetic resonance imaging (MRI) has a high soft tissue resolution, time and spatial resolution, abdominal MRI can noninvasively, dynamically detect the liver, spleen, portal system functions, the changes of portal system hemodynamics, blood supply of liver tissue, perfusion and liver cell function, etc.

In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used before and after transjugular intrahepatic portosystemic shunt. We will combine a variety of advanced magnetic resonance imaging technology, long-term and dynamic monitor TIPS preoperative and postoperative liver function, blood flow, perfusion, the change of tissue elasticity, and analysis the incidence of hepatic encephalopathy, hemorrhage, hepatic failure and survival rate with MRI changes. Finally, we will develop new prediction index, guide TIPS precision shunts, evaluate a variety of the value of imaging technology in the application of patients with TIPS to find the most sensitive technology, and discover the correlation between MRI function parameters with patient's survival. In order to analyze the liver function and survival of liver cirrhosis patients after transjugular intrahepatic portosystemic shunt, advanced magnetic resonance techniques are used to evaluate liver function, blood flow, elasticity, perfusion of before and after transjugular intrahepatic portosystemic shunt.


Condition or disease Intervention/treatment
Liver Cirrhosis Transjugular Intrahepatic Portosystemic Shunt (TIPS) Functional Magnetic Resonance Imaging Procedure: TIPS

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Advanced Magnetic Resonance Technics for the Assessment of Liver Function Before and After Transjugular Intrahepatic Portosystemic Shunt
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
Decompensated liver cirrhosis with TIPS Procedure: TIPS
TIPS: Established distributary channel between the portal vein and hepatic vein via the jugular vein, portal vein blood directly shunts into the systemic circulation to reduce portal vein pressure to effectively prevent bleeding and refractory ascites.




Primary Outcome Measures :
  1. mortality rate [ Time Frame: 5 years ]
  2. Incidence of hepatic encephalopathy [ Time Frame: 5 years ]
  3. Varices rebleeding rate [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Decompensated liver cirrhosis, secondary prevention with TIPS
Criteria

Inclusion Criteria:

  • 18-75 years old;
  • Liver cirrhosis (diagnosis by imaging, laboratory examination, clinical symptoms and liver biopsy);
  • History of endoscopy confirmed esophageal varicose vein hemorrhage (5 days or higher);
  • The Child-Pugh, B or C less 13;
  • Willing to participate in this clinical study, and sign an informed consent.

Exclusion Criteria:

  • Child-Pugh ≥12 or MELD ≥18;
  • Non-cirrhotic portal hypertension (including regional portal hypertension); total bilirubin over 2 times upper;
  • Combined liver cancer or other malignant tumor;
  • Infection, uncontrolled sepsis, etc.;
  • Heart, lung, kidney and other organs, severe disease;
  • Women during pregnancy or lactation.

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): NCT03933891


Contacts
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Contact: Xuefeng Luo, MD,PhD +86 18980606826 luo_xuefeng@yeah.net
Contact: Yuling Yan, MD,PhD +86 13648056747 yanyuling1991@126.com

Locations
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China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610000
Contact: Xuefeng Luo, MD,PhD         
Sponsors and Collaborators
West China Hospital
Investigators
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Study Director: Li Yang, MD,PhD West China Hospital
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Responsible Party: luo xuefeng, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03933891    
Other Study ID Numbers: TIPS-MRI
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by luo xuefeng, West China Hospital:
TIPS
functional MRI
liver corrhosis
portal hypertension
HVPG
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases