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

NCT03933891 | Unknown

• 1 other identifier: TIPS-MRI
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Functional Magnetic Resonance Imaging; Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Keywords

TIPS; functional MRI; liver corrhosis; portal hypertension; HVPG

Outcome Measures

Primary Outcomes (3)

• mortality rate

  5 years

• Incidence of hepatic encephalopathy

  5 years

• Varices rebleeding rate

  5 years

Study Arms (1)

Decompensated liver cirrhosis with TIPS

Procedure: TIPS

Interventions

TIPS PROCEDURE

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.

Decompensated liver cirrhosis with TIPS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Decompensated liver cirrhosis, secondary prevention with TIPS

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Li Yang, MD，PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Xuefeng Luo, MD，PhD

CONTACT

+86 18980606826; luo_xuefeng@yeah.net

Yuling Yan, MD，PhD

CONTACT

+86 13648056747; yanyuling1991@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: May 1, 2019
• Study Start: August 28, 2018
• Primary Completion: August 30, 2024
• Study Completion: May 30, 2025
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CN (1)