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临床试验/NCT05193253
NCT05193253已完成不适用

Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less Using an Intention-to-treat Analysis: a Retrospective Cohort Study

University Health Network, Toronto0 个研究点目标入组 119 人开始时间: 2000年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
主要终点
Intention-to-treat (ITT) overall survival

研究概览

简要总结

Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. We sought to evaluate the oncologic outcomes of patients who received either RFA, LR, or LT as first-line treatment for solitary HCC ≤ 3cm in an intention-to-treat analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥18 years) patients
  • Solitary HCC ≤ 3cm
  • Receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant
  • Treatment received between Feb-2000 and Nov-2018

排除标准

  • Pathology other than hepatocellular carcinoma (HCC)
  • Receipt of prior treatment (i.e., not treatment naive)
  • Not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing)
  • Platelet count <100,000 before treatment
  • Alpha-1 fetoprotein (AFP) level > 1000 before treatment
  • Age > 70 years
  • Child-Pugh score C
  • Esophageal varices grade greater than 2
  • Model for End-stage Liver Disease (MELD) score before treatment exceeding 15
  • Presence of ascites pretreatment
  • Presence of encephalopathy pretreatment
  • Spleen size greater than 12 cm

结局指标

主要结局

Intention-to-treat (ITT) overall survival

时间窗: Overall (median length of follow up of entire cohort 6.6 years)

ITT was evaluated from the first treatment modality that was selected for curative intent. In the case of RFA and LR this was recorded as the time of the treatment. In the case of LT, the intention-to-treat was recorded at the time of listing for transplantation. The ITT analysis thus accounted for patients who were placed on the waitlist but dropped out.

Disease-free survival (DFS).

时间窗: Overall (median length of follow up of entire cohort 6.6 years)

DFS was defined as the time after treatment during which the patient was alive and free of disease. For DFS, patients were censored at recurrence, death, or loss to follow up.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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