UVA Health Review Examines Real-World Results of Incisionless Liver Tumor Treatment

A new UVA Health review of nearly 1,000 patients treated with an incisionless procedure for liver tumors found low rates of laboratory toxicity and procedural complications, but researchers say the results also point to an important question: Which patients are most likely to benefit from the treatment?

The procedure, called histotripsy, uses focused sound waves to create tiny air bubbles within diseased liver tissue that can destroy cancer cells. It requires no surgical incision and is typically performed as an outpatient procedure without a hospital stay.

Histotripsy received clearance from the U.S. Food and Drug Administration in 2023 following early clinical studies that showed encouraging procedural safety and technical effectiveness in carefully selected patients.

UVA Health surgical oncologist Allan Tsung, MD, and his colleagues wanted to learn what happened as the technology moved beyond those early studies and into wider use.

The researchers reviewed outcomes from 972 patients who underwent histotripsy between 2023 and 2026. They examined patient survival, liver function before and after treatment, the risk of kidney injury, and other measures.

Their review found low rates of laboratory toxicity and procedural complications. At the same time, 11% of the patients died within 30 days of treatment.

The study does not establish that histotripsy caused those deaths.

Instead, researchers said the combination of relatively low procedural toxicity and the 30-day mortality rate raises questions about whether some patients had cancers that were already too advanced for them to receive meaningful benefit from a treatment focused on 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, chair of UVA Health’s Department of Surgery. “That does not mean histotripsy caused those deaths.”

Tsung said the results point to the need for doctors to better identify patients who have the type and stage of cancer most likely to benefit from the procedure.

“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,” he said.

Treating Cancer Without an Incision

Histotripsy differs from traditional surgery because doctors do not have to make an incision to reach the tumor.

Focused sound waves are directed at the diseased area of the liver, creating bubbles that mechanically destroy targeted cancer cells.

The approach offers an additional option for treating liver tumors, but the UVA researchers found that its real-world use has extended to many patients with advanced cancers.

Nearly 70% of the treatments included in the review were performed on patients with metastatic cancer involving the liver. That group included patients with pancreatic cancer.

Metastatic cancer has spread from its original location to another part of the body. In those cases, destroying tumors in the liver addresses one location of a disease that may be present elsewhere.

That raises an important issue when doctors and patients consider histotripsy: Even when the liver procedure itself can be performed safely, will treating those tumors provide enough benefit for a patient with advanced disease?

The researchers said timing deserves particular attention for patients with limited life expectancy.

“Just because we can perform a treatment safely does not mean it is the right treatment for every patient,” Tsung said.

He described histotripsy as a promising technology but said research now needs to help doctors determine how best to use it.

“I hope this research helps move the conversation from ‘Can we do it?’ to ‘When should we do it, and for whom?’” Tsung said. “Ultimately, our goal is to make sure that innovation translates into meaningful benefit for patients.”

Study Looks Beyond Early Clinical Trials

The distinction between early clinical studies and real-world use is an important part of the research.

Clinical studies may involve carefully selected patients who meet specific requirements. Once a new medical technology becomes more widely available, it may be used in patients with a wider range of health conditions and disease stages.

By examining 972 patients treated during the first several years of histotripsy’s availability, the UVA team sought to better understand those real-world outcomes.

The results do not conclude that the procedure is responsible for the 30-day deaths. Rather, the researchers say the findings show a need to better understand patient selection, particularly when someone has advanced metastatic cancer.

That distinction could become increasingly important as the technology’s use expands.

The findings were published in the scientific journal JAMA Network Open, where the article was selected as an Editor’s Pick. The research article is open access and available to the public.

The research team included Olivia Sears, Elio R. Bitar, Kaelyn C. Cummins, Natalie Blatz, Maclean Cook, Daniel Sheeran, and Tsung. UVA Health noted that Sheeran has served on the HistoSonics Prior Medical Advisory Board.

For Tsung and his colleagues, the review does not close the book on histotripsy. Instead, it points to the next questions doctors need to answer as the treatment becomes more widely used—particularly which patients stand to gain the most.