Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 主要终点
- Rates of local recurrence
研究概览
简要总结
Since the previous decade, the authors introduced the R1 vascular (R1vasc) resection for the treatment of hepatocellular carcinoma (HCC), and colorectal liver metastases (Torzilli et al. J Am Coll Surg 2005; Viganò et al. Ann Surg Oncol 2016; Torzilli et al. Surgery 2017). However, oncological reliability of tumor exposure in surgery for HCC remains controversial since it has never been validated. The aim of the study is to determine the oncological adequacy of R1vasc hepatectomy in patients with HCC.
详细描述
A prospective cohort of patients who underwent hepatectomy for HCC between January 2005 and December 2015 is reviewed. The following definitions are adopted: R0 is any resection with at least 1 mm of negative margin; R1vasc is any resection with tumor exposure due to the detachment from major intrahepatic vessel (1st/2nd order glissonean pedicles and hepatic vein at caval confluence); R1-parenchymal (R1par) is any resection with tumor exposure at parenchymal margin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •only patients with a primary untreated HCC were included;
- •complete follow-up data with available computed tomography (CT) and/or magnetic resonance imaging (MRI) images showing the first recurrence
排除标准
- •patients who underwent vascular resection for direct infiltration of the vessel wall
- •patients who had radiofrequency ablation in association to surgery
结局指标
主要结局
Rates of local recurrence
时间窗: From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months
Calculation of the local recurrence (cut-edge tumor re-growth) of R0, R1par, and R1vasc, and R1par+R1vasc hepatectomy.
次要结局
未报告次要终点
研究者
Matteo Donadon
Assistant professor of surgery, staff surgeon
Humanitas Clinical and Research Center