Elective Transjugular Intrahepatic Portosystemic Shunt Creation in Cirrhosis Improves Body Composition and Function: Pilot Randomized Trial.

PURPOSE: Sarcopenia and frailty are major determinants of morbidity and mortality in cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) creation for refractory ascites may reverse muscle loss, but prospective evidence is lacking.

MATERIALS AND

METHODS

In this single-center pilot randomized controlled trial, 26 cirrhotic adults with non-emergent complications of portal hypertension were allocated to standard of care (SOC) or SOC + TIPS creation. Fourteen completed six-month follow-up. Primary outcomes were the CT-derived skeletal (SMI) and psoas (PMI) muscle indices, adiposity, Short Physical Performance Battery, and Liver Frailty Index at baseline and at 6 months. Secondary outcomes included quality of life (QOL), MELD score, adverse events, and survival.

RESULTS

In the TIPS cohort, SMI and PMI increased significantly (both p < 0.05), along with increases in multiple adiposity indices (p < 0.05). In contrast, no body composition metrics showed significant changes in the SOC cohort. Between cohorts, the TIPS group showed significantly greater improvements in PMI (p < 0.05), subcutaneous adipose tissue index (p < 0.01), and intermuscular fat (p < 0.05). A ≥ 10% SMI rise occurred in 71% (5/7, TIPS) versus 14% (1/7, SOC) of patients. All functional scores improved in the TIPS cohort (p < 0.05), with no significant changes in the SOC cohort and significant between-cohort differences (p < 0.05). There were no differences between cohorts in hepatic encephalopathy, MELD scores, or survival (p > 0.05).

CONCLUSION

In this pilot randomized trial, TIPS creation appeared to improve body composition, physical function, and QOL in cirrhotic patients without increasing adverse events. Larger trials are needed to confirm its effects on sarcopenia and frailty.

LEVEL OF EVIDENCE: Level 1, Randomized Controlled Trial.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT05420753).