Biopsy-all strategy in patients with a renal mass: simulation of a randomised controlled trial

Kidney cancer poses a significant diagnostic and therapeutic challenge. Many patients with a renal mass undergo immediate surgery without a prior biopsy, which inevitably leads to overtreatment in cases where the lesion is ultimately benign. This approach, long established in clinical practice, exposes patients to surgical risks and complications that could have been avoided, while also increasing healthcare expenditures.

To explore whether systematic use of renal biopsy could provide clinical and economic benefits, researchers analyzed data from a large cohort of 1,729 patients with localized renal masses (cT1–2 cM0) who underwent upfront surgery. The study simulated a randomized clinical trial comparing two strategies: one in which all patients proceeded directly to surgery, and another in which all patients first underwent renal biopsy, with surgery reserved only for those with malignant or uncertain histology.

The simulation accounted for real-world limitations, including an 8–20% rate of inconclusive biopsy results and a very low complication rate associated with the biopsy procedure (0.07%). Outcomes of interest included the percentage of surgeries avoided, reduction in postoperative complications classified according to the Clavien–Dindo system, and differences in healthcare costs per patient.

The simulation showed that a "biopsy-all" strategy would have prevented 6.7% of surgeries, reduced total complications by 3%, grade >II complications by 2.5%, and more serious complications (grade >III) by 0.5%. In addition, the average savings per patient was $840.

In summary, adopting a non-selective renal biopsy strategy prior to surgery in patients with renal masses could prevent a substantial number of unnecessary operations, modestly decrease the burden of surgical complications, and reduce costs to the healthcare system.

Although not every biopsy provides a definitive diagnosis, the overall benefits of this approach support its consideration as a more targeted and sustainable strategy for managing renal masses.

Belladelli, F., Rosiello, G., Salerno, L., Musso, G., Cei, F., Re, C., Folcia, A., Fallara, G., Matloob, R., Branger, N., Walz, J., Salonia, A., Briganti, A., Montorsi, F., Bertini, R., Capitanio, U. and Larcher, A. (2025), Biopsy-all strategy in patients with a renal mass: simulation of a randomized controlled trial. BJU Int. https://doi-org.sanraffaele.idm.oclc.org/10.1111/bju.16885

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