Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation for Sarcopenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oregon Health and Science University, Portland, OR
Sarcopenia+3 More
Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. Creating a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is used to treat Sarcopenia, and has been approved by the FDA for a different condition. This treatment is free for patients in this trial, and they will not receive a placebo.

Eligible Conditions

  • Sarcopenia
  • Cirrhosis of the Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Start to 30 days after transplant

Year 2
Body composition changes
Overall survival
Day 30
Transplant complications
Month 6
Cardiac function
Chronic Liver Disease Quality of Life Questionnaire
IL-6 biomarker assessment
Lipocalin-2 biomarker assessment
Liver Frailty test
Liver function tests
Salivary cortisol biomarker assessment
Short Performance Physical Battery test
Stool microbiome genomic assessment
Month 6
Cardiac mass
Serum ammonia
Serum glucose

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard of care
1 of 2
TIPS
1 of 2
Active Control
Experimental Treatment

22 Total Participants · 2 Treatment Groups

Primary Treatment: Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation · No Placebo Group · Phase < 1

TIPS
Procedure
Experimental Group · 1 Intervention: Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation · Intervention Types: Procedure
Standard of careNoIntervention Group · 1 Intervention: Standard of care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: start to 30 days after transplant
Closest Location: Oregon Health and Science University · Portland, OR
Photo of oregon health and science university 1Photo of oregon health and science university 2Photo of oregon health and science university 3
2012First Recorded Clinical Trial
1 TrialsResearching Sarcopenia
533 CompletedClinical Trials

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
880 Previous Clinical Trials
6,826,785 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have portal vein thrombosis.
Patients aged 18 years or older with cirrhosis should be considered for liver transplantation.
You have ascites or hydrothorax requiring escalation of diuretic medication.
You have ascites or hydrothorax despite diuretic use, or intolerance of diuretic use.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.