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Body Composition Changes After TIPS and Associated Clinical Outcomes

Description

The purpose of this study is to prospectively assess the impact of TIPS creation on muscle mass and physical function in patients with cirrhosis, and to determine whether these changes correlate with improved outcomes in patients awaiting liver transplantation. Retrospective observational studies have shown improvement in muscle mass and body composition in cirrhotic patients undergoing TIPS. The investigators aim to now prospectively study this through a pilot randomized controlled trial tracking patients managed with TIPS creation compared to those managed without TIPS to determine whether these observational findings can be seen in a randomized cohort. The investigators hypothesize that TIPS creation will lead 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 that these changes will improve liver disease outcomes in patients awaiting liver transplantation.

Conditions

Cirrhosis, LiverSarcopenia
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Related Conditions:

Cirrhosis, LiverSarcopenia

Study Overview

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Study Details

Study overview

The purpose of this study is to prospectively assess the impact of TIPS creation on muscle mass and physical function in patients with cirrhosis, and to determine whether these changes correlate with improved outcomes in patients awaiting liver transplantation. Retrospective observational studies have shown improvement in muscle mass and body composition in cirrhotic patients undergoing TIPS. The investigators aim to now prospectively study this through a pilot randomized controlled trial tracking patients managed with TIPS creation compared to those managed without TIPS to determine whether these observational findings can be seen in a randomized cohort. The investigators hypothesize that TIPS creation will lead 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 that these changes will improve liver disease outcomes in patients awaiting liver transplantation.

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

Body Composition Changes After TIPS and Associated Clinical Outcomes

Condition
Cirrhosis, Liver
Intervention / Treatment

-

Contacts and Locations

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oregon Health and Science University,

Study Record Dates

2025-12-31