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Procedure

TIPS Procedure for Liver Cirrhosis and Muscle Loss

Phase < 1
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Portal hypertensive gastropathy and blood loss anemia
Chronic portal vein thrombosis requiring recanalization and TIPS for transplant
Must not have
Decisionally impaired individuals
Recurrent overt hepatic encephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start to 30 days after transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether TIPS creation leads to improved muscle mass, body composition and muscle function within the first 12 months after the procedure compared to a control group without TIPS, and whether these changes improve liver disease outcomes in patients awaiting liver transplantation.

Who is the study for?
This trial is for adults aged 18-99 with cirrhosis listed for liver transplant, experiencing complications like persistent fluid buildup or bleeding due to portal hypertension. It's not suitable for those with frequent brain function issues from liver disease, severe clotting problems, current infections, pregnancy, urgent need for TIPS, no other treatment options, active cancer outside the liver or a MELD score over 25.
What is being tested?
The study tests if creating a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in cirrhotic patients improves muscle mass and physical function compared to those without TIPS. The goal is to see if these changes lead to better outcomes while waiting for a liver transplant.
What are the potential side effects?
Potential side effects of TIPS include worsening of brain function issues related to the liver disease (encephalopathy), internal bleeding risks due to altered blood flow in the veins of the esophagus or stomach lining and potential injury during shunt placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stomach issues due to liver problems and anemia from bleeding.
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I need a procedure to open a blocked vein in my liver for a transplant.
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I am between 18 and 99 years old, have cirrhosis, and am on the liver transplant list.
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I have increased fluid in my abdomen or chest needing more water pills.
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I have ongoing fluid buildup in my abdomen or chest despite using water pills, or I cannot tolerate these pills.
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I have had bleeding from enlarged veins in my stomach or esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to make my own medical decisions.
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I have had more than one episode of severe confusion due to liver problems.
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I have no other treatment options besides TIPS for my condition.
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I need an emergency procedure to create a pathway in my liver.
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I have a blood infection.
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I have liver cancer or another active cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start to 30 days after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and start to 30 days after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body composition changes
Liver Frailty test
Short Performance Physical Battery test
Secondary study objectives
Cardiac function
Cardiac mass
Chronic Liver Disease Quality of Life Questionnaire
+5 more
Other study objectives
IL-6 biomarker assessment
Lipocalin-2 biomarker assessment
Salivary cortisol biomarker assessment
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TIPSExperimental Treatment1 Intervention
Patients in this arm will undergo TIPS creation in addition to their current management.
Group II: Standard of careActive Control1 Intervention
Patients in this arm will continue to be treated with their current management

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,897 Total Patients Enrolled

Media Library

Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05420753 — Phase < 1
Liver Cirrhosis Research Study Groups: TIPS, Standard of care
Liver Cirrhosis Clinical Trial 2023: Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation Highlights & Side Effects. Trial Name: NCT05420753 — Phase < 1
Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05420753 — Phase < 1
~7 spots leftby Dec 2025
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