RECRUITING

Body Composition Changes After TIPS and Associated Clinical Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05420753

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients \>18 \<99 with cirrhosis wait listed for liver transplantation
  2. * Evidence of complications of portal hypertension:
  3. * Ascites or hydrothorax requiring escalation of diuretic medication
  4. * Persistent ascites or hydrothorax despite diuretic use, or intolerance of diuretic use
  5. * Gastrointestinal varices and blood loss anemia or history of variceal hemorrhage
  6. * Portal hypertensive gastropathy and blood loss anemia
  7. * Chronic portal vein thrombosis requiring recanalization and TIPS for transplant
  1. * Hepatocellular carcinoma or other active malignancy
  2. * Recurrent overt hepatic encephalopathy
  3. * Uncontrolled coagulopathy with maximum amplitude (MA) \<30 on thromboelastography
  4. * Bacteremia or sepsis
  5. * MELD \> 25
  6. * Pregnant
  7. * Decisionally impaired individuals
  8. * Need for emergency TIPS creation
  9. * Patients who do not have acceptable alternatives to TIPS creation to manage their disease

Contacts and Locations

Study Contact

Khashayar Farsad, MD
CONTACT
503-494-7660
farsad@ohsu.edu
Lori Russell, RN
CONTACT
503-494-7660
watsonlo@ohsu.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-05-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • cirrhosis
  • liver transplantation
  • sarcopenia
  • frailty

Additional Relevant MeSH Terms

  • Cirrhosis, Liver
  • Sarcopenia