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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
Oregon Health and Science University
RECRUITING
Portland
Contact Information
Primary
Khashayar Farsad, MD
farsad@ohsu.edu
503-494-7660
Backup
Lori Russell, RN
watsonlo@ohsu.edu
503-494-7660
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 22
Treatments
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
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov

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