Body Composition Changes After TIPS and Associated Clinical Outcomes

NCT05420753 | Unknown Early Phase 1 DMC

• 1 other identifier: STUDY00022853
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

cirrhosis; liver transplantation; sarcopenia; frailty

Outcome Measures

Primary Outcomes (3)

• Body composition changes

  Muscle and fat content as assessed by CT scan

  Start to 2 years after enrollment

• Short Performance Physical Battery test

  Brief physical test for balance with feet together (seconds), gait speed walking 4 meters (seconds), time to stand from a chair (seconds). These are aggregated together to a unified score.

  Start to 6 months after enrollment

• Liver Frailty test

  Brief physical test for balance with feet together (seconds), time to stand from a chair (seconds), and grip strength (kilograms of force). These are aggregated together to a unified score.

  Start to 6 months after enrollment

Secondary Outcomes (8)

• Chronic Liver Disease Quality of Life Questionnaire

  Start to 6 months after enrollment

• Overall survival

  Start to 2 years after enrollment

• Transplant complications

  Start to 30 days after transplant

• Cardiac function

  Start to 6 months after enrollment

• Liver function tests

  Start to 6 months after enrollment

Other Outcomes (4)

• Stool microbiome genomic assessment

  Start to 6 months after enrollment

• Lipocalin-2 biomarker assessment

  Start to 6 months after enrollment

• IL-6 biomarker assessment

  Start to 6 months after enrollment

Study Arms (2)

TIPS

EXPERIMENTAL

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

Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation

Standard of care

NO INTERVENTION

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

Interventions

Transjugular Intrahepatic Portosystemic Shunt (TIPS) creation PROCEDURE

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.

TIPS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Sarcopenia; Fibrosis; Frailty

Interventions

Portasystemic Shunt, Transjugular Intrahepatic; Facility Design and Construction

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Architecture; Technology, Industry, and Agriculture; Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Khashayar Farsad, MD

CONTACT

503-494-7660; farsad@ohsu.edu

Lori Russell, RN

CONTACT

503-494-7660; watsonlo@ohsu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: June 15, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)