Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Procedure: conventional lymph node dissection; Procedure: unconventional lymph node dissection

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wu Dong, MD; Phone Number: 0086-021-25070765; Email: wuyuz@yahoo.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200438
      • Recruiting
      • Eastern hepatobilliary surgery hospital
      • Contact: Wu Dong, MD; Phone Number: 0086-021-25070765; Email: wuyuz@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional lymph node dissection; conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma	Procedure: conventional lymph node dissection; conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Active Comparator: unconventional lymph node dissection; unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma	Procedure: unconventional lymph node dissection; unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	five years

Secondary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	five years

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital
• Investigators: Study Chair: Shen Feng, MD, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: lymph node dissection
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: EHBHLND-2015-8-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No