UVA study evaluates safety and real-world outcomes of histotripsy

Early clinical studies that led the federal Food and Drug Administration to clear the procedure in 2023 demonstrated encouraging procedural safety and technical effectiveness in carefully selected patients. But UVA's Allan Tsung, MD, and colleagues wanted to see how that has played out in the real world. They examined outcomes from 972 patients who underwent the procedure between 2023 and 2026, looking at factors such as patient survival, liver function before and after histotripsy and the chances of kidney injury.

Their findings showed low rates of laboratory toxicity and procedural complications, yet the researchers noted that 11% of patients died within 30 days. Although the study cannot determine whether histotripsy contributed to these deaths, Tsung said the low rates of procedural toxicity suggest that advanced cancer and overall disease burden may have contributed to the observed mortality. The findings raise questions about whether some patients with advanced disease may have had too limited a life expectancy to meaningfully benefit from a treatment directed specifically at tumors in the liver.

Histotripsy and its use

Histotripsy uses focused sound waves to create air bubbles within the diseased liver that can destroy cancer cells. It is typically performed as an outpatient procedure, requiring no hospital stay. But the researchers found that nearly 70% of treatments were performed in patients with metastatic cancer involving the liver, including patients with pancreatic cancer. This raised questions for Tsung and his colleagues about which patients with metastatic disease are most likely to benefit from a treatment directed specifically at liver tumors.

"Just because we can perform a treatment safely does not mean it is the right treatment for every patient," Tsung said. "Histotripsy is a promising technology, and I hope this research helps move the conversation from 'Can we do it?' to 'When should we do it, and for whom?' Ultimately, our goal is to make sure that innovation translates into meaningful benefit for patients."

Findings published

Source:

University of Virginia Health System

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