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临床试验/NCT04412161
NCT04412161已完成不适用

Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter > 6 cm).

Inonu University0 个研究点目标入组 50 人开始时间: 2006年4月19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
50
主要终点
overall and disease free survivals

研究概览

简要总结

Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with >6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP <200 ng/ml and GGT <104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.

详细描述

Background:A retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCs,to examine possible prognostically-useful factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were identified. Their survival and full clinical characteristics were examined, with respect to serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT 104 IU/ml were identified and used in this study. Significantly longer overall-survival and disease-free-survival were found for patients who had lower values of either parameter, compared with higher values.Even greater differences in survival were found when the 2 parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasion.Two tumor size bands were identified,to search for the limits of this approach with larger tumors, namely 6-10 and >10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma

排除标准

  • Early postoperative mortality (within 90 days)
  • Advanced stage tumors (explant patology revealed that tumor continues in the surgical cite such as positive lymph node metastases, macroscopic portal vein trombosis, diaphragmatic invasion, etc)

结局指标

主要结局

overall and disease free survivals

时间窗: five years follow up

to analyse the factors that effect the survivals

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Volkan Ince

MD, FEBS, Assoc.Prof

Inonu University

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