Clinical Trial: Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Eastern Hepatobiliary Surgery Hospital

Current Primary Outcome: overall survival [ Time Frame: five years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: disease-free survival [ Time Frame: five years ]

Original Secondary Outcome: Same as current

Information By: Eastern Hepatobiliary Surgery Hospital

Dates:
Date Received: August 10, 2015
Date Started: August 2015
Date Completion: December 2017
Last Updated: March 30, 2016
Last Verified: March 2016