Impact of TIPS on muscle mass and outcomes in cirrhosis patients
Single-center Randomized Controlled Trial to Evaluate Body Composition Changes and Clinical Outcomes After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation in Patients With Cirrhosis and Complications of Portal Hypertension Awaiting Liver Transplantation
This study is testing whether getting a TIPS procedure helps people with cirrhosis gain muscle mass and improve their physical function while they wait for a liver transplant.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05420753 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively evaluate how the creation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) affects muscle mass and physical function in patients with cirrhosis awaiting liver transplantation. It will compare patients undergoing TIPS with those who are not, tracking changes in body composition and muscle function over the first 12 months post-procedure. The goal is to determine if improvements in muscle mass correlate with better clinical outcomes in this population, building on previous observational findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 with cirrhosis who are on the liver transplant waiting list and have complications related to portal hypertension.
Not a fit: Patients with active malignancies, uncontrolled coagulopathy, or those requiring emergency TIPS creation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle mass and better clinical outcomes for patients with cirrhosis awaiting liver transplantation.
How similar studies have performed: Previous observational studies have indicated positive outcomes with similar approaches, but this study represents a novel prospective evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 \<99 with cirrhosis wait listed for liver transplantation * Evidence of complications of portal hypertension: * Ascites or hydrothorax requiring escalation of diuretic medication * Persistent ascites or hydrothorax despite diuretic use, or intolerance of diuretic use * Gastrointestinal varices and blood loss anemia or history of variceal hemorrhage * Portal hypertensive gastropathy and blood loss anemia * Chronic portal vein thrombosis requiring recanalization and TIPS for transplant Exclusion Criteria: * Hepatocellular carcinoma or other active malignancy * Recurrent overt hepatic encephalopathy * Uncontrolled coagulopathy with maximum amplitude (MA) \<30 on thromboelastography * Bacteremia or sepsis * MELD \> 25 * Pregnant * Decisionally impaired individuals * Need for emergency TIPS creation * Patients who do not have acceptable alternatives to TIPS creation to manage their disease
Where this trial is running
Portland, Oregon
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Khashayar Farsad, MD
- Email: farsad@ohsu.edu
- Phone: 503-494-7660
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.