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Liver CirrhosisNCT03933891

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

An observational study of Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPS), run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TIPS
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteChina
Study dates
28 Aug 2018to 30 May 2025
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Decompensated liver cirrhosis, secondary prevention with TIPS

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Xuefeng Luo, MD,PhD contact

+86 18980606826

luo_xuefeng@yeah.net

Yuling Yan, MD,PhD contact

+86 13648056747

yanyuling1991@126.com

China1 site, 1 recruiting
  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Xuefeng Luo, MD,PhD

    Recruiting

Other trials in China

About this study

Official title: Advanced Magnetic Resonance Technics for the Assessment of Liver Function Before and After Transjugular Intrahepatic Portosystemic Shunt

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.

Read the detailed description

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. Magnetic resonance 4D-flow imaging, can accurately measure the portal vein system blood vessels and shunt channels, blood volume, flow velocity parameters of blood flow can be detected. Recent studies have confirmed that the 4D-flow technology can accurately, long-term follow-up monitoring TIPS preoperative, postoperative portal vein blood flow, which have better sensitivity and more accurate than ultrasound to detect blood flow. Magnetic resonance perfusion imaging of the liver can quantitatively obtain liver tissue microcirculation status, monitor portal vein and hepatic artery blood perfusion, the liver perfusion has a significant correlation with Child-Pugh score and degree of liver fibrosis and cirrhosis of the liver. Compared with the traditional magnetic resonance imaging contrast agents, liver specific contrast agents have small renal toxicity, uptake by liver cell specificity, recent studies have found that magnetic resonance imaging with liver cell specificity contrast agents have significantly correlated with the stage of fibrosis of the liver and liver function, and has been used in the clinical staging of liver fibrosis and early detection of hepatocellular carcinoma (HCC). Magnetic resonance elastography (MRE) is a new imaging technology in recent years and a unique image method. As a noninvasive and quantitative method to detect elastic properties of the organ. Plenty of research results showed that in patients with liver cirrhosis, liver and spleen of elasticity have significant correlation with the degree of portal hypertension. So far, a variety of functional imaging methods grade and guide prognosis of patients with cirrhosis, which have been confirmed to have significant clinical value. MRE has been written for the latest diagnosis and treatment of portal hypertension guidelines.

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. Researchers 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, Researchers will develop a new predictive 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.

Materials and Methods Patients 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 longer); 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; There are other contraindications to TIPS, EVL and NSBB treatment; heart, lung, kidney and other organs severe disease; women during pregnancy or lactation.

The patients' information Basic information: name, age, gender, work, BMI, rural/urban; Past medical history: the presence of a stool and hemoptysis, ligation hemostasis under gastroscopy history; History of ascites; Hepatic encephalopathy history; Drugs make: diuretics, B-blocker; With or without cardiopulmonary dysfunction history. Cause: alcoholic liver cirrhosis; HBV/HCV related cirrhosis of the liver; AIH, PBC, others. TIPS surgery reason: gastrointestinal bleeding, ascites, other. TIPS postoperative complications: hepatic encephalopathy, ascites, varicose vein bleeding, kidney failure, liver failure. Before and after TIPS, 96 hours, 1 month, 3 months, 6 months and 12 months, then each half year to follow-up until to 5 years. Physical signs and symptoms, Child-Pugh score, MELD score, ammonia and platelet are collected. Before and after TIPS, 96 hours, 6 months and 12 months, multi parameters MRI is performed. MRI scan parameters: 4D-flow sequence: the respiratory gating and cardiac switch control, phase code acquisition of three- space, to obtain parameters of blood flow parameters mapping images. Imaging parameters: imaging volume, 32 × 32 ×24 cm2 to get the isotropic spatial resolution 1.25 mm. TR/TE: 6.4ms/2.2ms, Flip Angle: 16 °. Imaging time is about 12 minutes, depending on the respiratory gating. MRE: simple principle is on the basis of common MRI scans, install a non-magnetic voltage sensor on patients to produce mechanical vibration that transfer into tissues and organs. Particle produce displacement in the direction of propagation of mechanical vibration. The size of the displacement associated with the level of organization elasticity. Imaging parameters are as follows: 3.0 T MR (GE), 12 channels of the surface phased array coil, respiratory gating, single-shot spin echo planar imaging sequence with flow compensation movement encoding gradient, Mechanical wave frequency, 25, 30, 40, 50, and 60 Hz; the spatial resolution: 2 × 2× 2.5 mm3, FOV: 384 x 256; repetition time: 1820 ms; echo time: 54 ms; Matrix: 192 x 128; Perfusion MRI: a 2D fast spoiled gradient echo multi flip-angle T1 map was produced before contrast agent injection with FOV: 60×60×40 mm3; thickness: 2.0 mm; TR:12.4 ms; TE:2.1 ms; matrix: 256 × 128; NEX: 1; with different flip angle 5°, 10°, 20°, 30°, 40°, 50°. The parameters of DCE-MRI were the same as those above, except the flip angle was 30°, after six phase baseline images, 0.025mM/kg Gd of Gd-EOB-DTPA, then 40 phase images were acquired. Liver specificity contrast agents enhanced imaging parameters: 3.0T MR, 12 channels on the surface phased array coil, VIBE: Volume Interpolated Breath-hold Examination, repetition time: 3.1 ms; echo time: 1.16 ms; reconstruction resolution size: 1.3 ×1. 3 × 1.3 mm3; The scanning resolution: 1.7 ×1. 3 ×1. 3 mm3. The MR functions parameters are collected: the liver, the spleen elasticity; 4 D-flow: the superior mesenteric vein (SMV), splenic vein (SV), portal vein (PV) of flow volume, pulse wave velocity (PWV); Perfusion: rCBV, rCBF, MTT; T1 mapping: liver, spleen and kidney T1 values; Magnetic resonance liver cell specificity of contrast agents enhancement: arterial phase, portal phase, liver and gall T1WI signal value of liver tissue. The MR function parameter changes as followed after TIPS will be analyzed. The MR function parameters with chemical biomarkers to predict survival will be analyzed.

Being tested
TIPS
Keywords
TIPS, functional MRI, liver corrhosis, portal hypertension, HVPG
Medical subject headings
Liver Cirrhosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIPSProcedure or surgery

    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.

Study groups in NCT03933891
Study groupRoleWhat they receive
Decompensated liver cirrhosis with TIPSNot described
Receives: Procedure: TIPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality rate

    Measured: 5 years

  2. Incidence of hepatic encephalopathy

    Measured: 5 years

  3. Varices rebleeding rate

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start28 Aug 2018
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 May 2025 (estimated)

Resources

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 only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03933891
Sponsor's protocol ID
TIPS-MRI
Status last verified
Apr 2019
First submitted
26 Sep 2018
Last updated
1 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPS), run by West China Hospital at 1 site in China.

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 5 inclusion and 6 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Xuefeng Luo, MD,PhD (+86 18980606826, luo_xuefeng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality rate (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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