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临床试验/NCT02526771
NCT02526771Unknown不适用

A Randomized Controlled Study of Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
overall survival

研究概览

简要总结

The aim of this study is to compare the surgical outcomes of conventional lymph node dissection with unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

详细描述

Intrahepatic cholangiocarcinoma (ICC) is one of the primary liver cancer, which has higher malignant, more difficult treatment and worse prognosis compared to hepatocellular carcinoma and its incidence continues to rise. The main radical treatment is surgical resection, however, postoperative recurrence rate is extremely high. The 3-year recurrence rate is more than 50%. It is reported that lymph node metastasis rate of ICC is as high as 20% to 65%, which is the most significant factor of the poor prognosis. The probability of lymph node metastasis is 13% when lymph nodes metastasis were not found preoperative or intraoperative. It is highly controversial whether or not to undergo conventional lymph node dissection when lymph nodes metastasis were not found preoperative or intraoperative . A number of researchers approved of lymph node dissection at that situation. However, some authors such as Kim suggest that lymph node resection is not necessary. Others such as Yang think should consider in different condition. Clark CJ thinks that the evidence for dissection or not of lymph node is insufficient in view of the above reasons, the investigators have planned to implement a randomized controlled study to confirm the prognostic value of conventional or unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female patients > 18 years and <=70 years of age.
  • •Diagnosis of intrahepatic cholangiocarcinoma ( through imaging, serology, intraoperative frozen, etc.)
  • •No lymph node metastasis preoperatively or intraoperatively.
  • •Tumors can be completely resected.
  • •Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  • •Patients who can understand this trial and have signed information consent.

排除标准

  • •Lymph node metastasis preoperatively.
  • •Tumors can not be resected .
  • •Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
  • •Patients with a medical history of other malignant tumors.
  • •Subjects participating in other clinical trials.
  • •liver function:Child C.

研究组 & 干预措施

conventional lymph node dissection

Experimental

conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

干预措施: conventional lymph node dissection (Procedure)

unconventional lymph node dissection

Active Comparator

unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

干预措施: unconventional lymph node dissection (Procedure)

结局指标

主要结局

overall survival

时间窗: five years

次要结局

  • disease-free survival(five years)

研究者

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

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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