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临床试验/NCT02319863
NCT02319863Unknown不适用

A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 1994年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
recurrence

研究概览

简要总结

This study examines the role of this simple technique on postoperative metastasis and long term survival.

详细描述

The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.

During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HCC patients who will perform left- or right- hemihepatectomy.

排除标准

  • contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)>30%,serum hepatitis B virus (HBV)-DNA>106 copies/ml and serum alanine aminotransferase (ALT)>2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
  • age of<18y or>65y

结局指标

主要结局

recurrence

时间窗: 12 months

to examine if there is intrahepatic recurrence

metastasis

时间窗: 12 months

to examine if there is intrahepatic metastasis and metastasis in distant organs

mortality

时间窗: 1 month

intraoperative death, and death in one month after surgery

次要结局

  • Prognosis(5 years)

研究者

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

Xiaoping Chen

professor

Huazhong University of Science and Technology

研究点 (1)

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