Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526771
• Other study ID #: EHBHLND-2015-8-10
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2015
• Last updated: March 30, 2016
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Shen Feng, MD
• Phone: 0086-021-25070805
• Email: shenfengdfgd[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Liver Neoplasms

Intervention

Procedure:
• conventional lymph node dissection
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
• unconventional lymph node dissection
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		five years	No
Secondary	disease-free survival		five years	No