Using MRI to assess liver function before and after TIPS procedure
Advanced Magnetic Resonance Technics for the Assessment of Liver Function Before and After Transjugular Intrahepatic Portosystemic Shunt
West China Hospital · NCT03933891
This study is trying to see how well a special MRI can check liver function in people with cirrhosis before and after they have a TIPS procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West China Hospital (other) |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT03933891 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate liver function in patients with cirrhosis undergoing a transjugular intrahepatic portosystemic shunt (TIPS) procedure using advanced magnetic resonance imaging (MRI) techniques. The study focuses on the use of noninvasive MRI methods, particularly 4D-flow imaging, to monitor hemodynamic changes and liver function before and after the TIPS intervention. By accurately measuring parameters such as blood flow and liver perfusion, the study seeks to improve patient outcomes and reduce postoperative complications associated with TIPS. Participants will be monitored for their liver function and overall prognosis following the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with liver cirrhosis and a history of esophageal variceal hemorrhage.
Not a fit: Patients with severe liver dysfunction (Child-Pugh ≥12 or MELD ≥18) or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and outcomes for patients undergoing TIPS, potentially reducing complications and enhancing survival rates.
How similar studies have performed: While the use of MRI in liver assessment is established, the specific application of 4D-flow imaging in the context of TIPS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
Study contacts
- Study coordinator: Xuefeng Luo, MD，PhD
- Email: luo_xuefeng@yeah.net
- Phone: +86 18980606826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Transjugular Intrahepatic Portosystemic Shunt, Functional Magnetic Resonance Imaging, TIPS, functional MRI, liver corrhosis, portal hypertension, HVPG