UVA Health researchers have reviewed patient outcomes from a new, noninvasive way to treat liver tumors called histotripsy and concluded that while the procedure was associated with low rates of laboratory toxicity and procedural complications, the findings highlight the need to better define which patients are most likely to benefit.
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.
“What surprised us was the contrast between how well patients tolerated the procedure itself and the number of patients who died within 30 days,” said Tsung, a surgical oncologist and chair of UVA Health’s Department of Surgery. “That does not mean histotripsy caused those deaths. What it does tell us is that we need to better understand which patients are most likely to live long enough and have the right type of cancer to meaningfully benefit from this treatment.”
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.
The researchers say the timing of histotripsy deserves careful consideration, particularly for patients with advanced disease and limited life expectancy. Even a treatment that can be performed safely may provide limited benefit if a patient's cancer is too advanced.
“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
The researchers have published their findings in the scientific journal JAMA Network Open , where the article was selected as an Editor’s Pick. The article is open access, meaning it is free to read. The research team consisted of Olivia Sears, Elio R. Bitar, Kaelyn C. Cummins, Natalie Blatz, Maclean Cook, Daniel Sheeran and Tsung. Sheeran has served on the HistoSonics Prior Medical Advisory Board.
To keep up with the latest medical research news from UVA and UVA’s new Paul and Diane Manning Institute of Biotechnology, bookmark the Making of Medicine blog at https://www.uvahealth.com/making-of-medicine .