Recruiting
Early Phase 1

TIPS

Sponsor:

Oregon Health and Science University

Code:

NCT05420753

Conditions

Cirrhosis, Liver

Sarcopenia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation

Study Details

Brief summary:

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, Liver

Sarcopenia

Study ID

NCT05420753

Start date

May 1, 2022

Status verified date

Nov, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TIPS

Patients in this arm will undergo TIPS creation in addition to their current management.

no intervention: Standard of care

Patients in this arm will continue to be treated with their current management

Interventions

Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation

During a TIPS procedure, the interventional radiologist, with the help of x-ray and ultrasound guidance, makes a channel through the liver to connect the portal vein (the vein that carries blood from the digestive organs to the liver) to one of the hepatic vein (three veins that carry blood away from the liver back to the heart) using a special type of needle. The interventional radiologist then replaces the needle with a wire and catheter, and a small tubular device called a stent graft is placed in this channel to keep the pathway open between the two blood vessels.

Primary outcome measure

  • Body composition changes [ Time Frame: Start to 2 years after enrollment ]
  • Short Performance Physical Battery test [ Time Frame: Start to 6 months after enrollment ]
  • Liver Frailty test [ Time Frame: Start to 6 months after enrollment ]

Central Contacts and Locations

Central contacts

Khashayar Farsad, MD

503-494-7660farsad@ohsu.edu

Lori Russell, RN

503-494-7660watsonlo@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Khashayar Farsad, MD

503-494-7660farsad@ohsu.edu

Lori Russell, RN

503-494-7660watsonlo@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Nov 7, 2023

Last verified

Nov, 2023

Keywords

  • cirrhosis
  • liver transplantation
  • sarcopenia
  • frailty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2023-11-07.