Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Procedure: conventional lymph node dissection; Procedure: unconventional lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT02526771

EHBHLND-2015-8-10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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. Exclusion Criteria: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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

conventional lymph node dissection

Experimental group

Description:

conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

Treatment:

Procedure: conventional lymph node dissection

unconventional lymph node dissection

Active Comparator group

Description:

unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

Treatment:

Procedure: unconventional lymph node dissection