Xiao Boyuan, Qian Zhiyu, Piccolini Andrea, Dagnino Filippo, Korn Stephan M, Zurl Hanna, Pohl Klara K, Stelzl Daniel R, Moore Caroline M, Wollin Daniel, Trinh Quoc-Dien, Cole Alexander P
Chobanian and Avedisian School of Medicine, Boston University, Boston, MA, USA.
Department of Urology, Brigham and Women's Hospital, Harvard Medical School, 45 Francis St, ASB II-3, Boston, MA, 02115, USA.
Int Urol Nephrol. 2025 Sep 9. doi: 10.1007/s11255-025-04766-x.
With the advancement of MR-based imaging, prostate cancer ablative therapies have seen increased interest to reduce complications of prostate cancer treatment. Although less invasive, they do carry procedural risks, including rectal injury. To date, the medicolegal aspects of ablative therapy remain underexplored. In this study, we aim to analyze malpractice lawsuits related to prostate cancer ablative therapies using a national legal database.
In this retrospective study, we utilized the LexisNexis Database to analyze ablative therapy malpractice lawsuits between 1970 and 2024. We searched for keywords "ablative therapy" "focal therapy" "high-intensity focused ultrasound" "HIFU" "cryotherapy" "cryoablation" "laser" "irreversible electroporation" and "IRE" We excluded cases that did not involve ablative treatment of prostate cancer. We then reviewed cases for treatment method, allegation, claimed liabilities, verdict, and plaintiff award.
We identified 180 lawsuits using the keywords provided, and 5 cases met inclusion criteria. All five lawsuits involved cryoablation for prostate cancer. The most common precipitating injury was rectal injury (3, 60%). Allegations included negligence (2, 25%), deviation from the standard of care (2, 25%), deliberate indifference (2, 25%), and failure to consent (2, 25%). Verdicts were predominantly favorable to defendants (4, 80%), and one case (20%) resulted in an unknown outcome.
Ablative therapy had a limited number of lawsuits, with outcomes favorable to surgeons and minimal financial payouts. As ablative therapy continues to gain popularity, urologists must practice proper surgical techniques, conduct thorough informed consent, and exercise excellent patient-provider communication to help minimize the occurrence and impact of litigations involving ablative therapy. These findings may help guide future patient risk counseling and support adjustments in malpractice insurance policies as the use of ablative therapies expands, while also informing physicians and hospital systems considering their adoption or expansion.
随着基于磁共振成像技术的发展，前列腺癌消融治疗越来越受到关注，以减少前列腺癌治疗的并发症。尽管侵入性较小，但它们确实存在手术风险，包括直肠损伤。迄今为止，消融治疗的法医学方面仍未得到充分探索。在本研究中，我们旨在使用国家法律数据库分析与前列腺癌消融治疗相关的医疗事故诉讼。
在这项回顾性研究中，我们利用LexisNexis数据库分析1970年至2024年间的消融治疗医疗事故诉讼。我们搜索了关键词“消融治疗”“聚焦治疗”“高强度聚焦超声”“HIFU”“冷冻疗法”“冷冻消融”“激光”“不可逆电穿孔”和“IRE”。我们排除了不涉及前列腺癌消融治疗的病例。然后，我们审查了病例的治疗方法、指控、索赔责任、判决和原告赔偿。
我们使用提供的关键词识别出180起诉讼，其中5起符合纳入标准。所有5起诉讼均涉及前列腺癌冷冻消融。最常见的致伤原因是直肠损伤（3例，60%）。指控包括疏忽（2例，25%）、偏离护理标准（2例，25%）、故意漠视（2例，25%）和未获得同意（2例，25%）。判决结果主要有利于被告（4例，80%），1例（20%）结果未知。
消融治疗的诉讼数量有限，结果有利于外科医生，经济赔偿 minimal。随着消融治疗越来越受欢迎，泌尿外科医生必须采用适当的手术技术，进行全面的知情同意，并与患者进行良好的沟通，以尽量减少涉及消融治疗的诉讼的发生和影响。这些发现可能有助于指导未来的患者风险咨询，并在消融治疗使用扩大时支持医疗事故保险政策的调整，同时也为考虑采用或扩大消融治疗的医生和医院系统提供信息。
