Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

Not Applicable

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Procedure: conventional lymph node dissection; Procedure: unconventional lymph node dissection

• Registration Number: NCT02526771
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

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 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional lymph node dissection	conventional lymph node dissection	conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
unconventional lymph node dissection	unconventional lymph node dissection	unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

Primary Outcome Measures

Name	Time	Method
overall survival	five years

Secondary Outcome Measures

Name	Time	Method
disease-free survival	five years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China