Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional lymph node dissection
unconventional lymph node dissection
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring lymph node dissection
Eligibility 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.
Sites / Locations
- Eastern hepatobilliary surgery hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
conventional lymph node dissection
unconventional lymph node dissection
Arm Description
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
disease-free survival
Full Information
NCT ID
NCT02526771
First Posted
August 10, 2015
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02526771
Brief Title
Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
Official Title
A Randomized Controlled Study of Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
lymph node dissection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional lymph node dissection
Arm Type
Experimental
Arm Description
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Arm Title
unconventional lymph node dissection
Arm Type
Active Comparator
Arm Description
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Intervention Type
Procedure
Intervention Name(s)
conventional lymph node dissection
Intervention Description
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Intervention Type
Procedure
Intervention Name(s)
unconventional lymph node dissection
Intervention Description
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Primary Outcome Measure Information:
Title
overall survival
Time Frame
five years
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Dong, MD
Phone
0086-021-25070765
Email
wuyuz@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Wu Dong, MD
Phone
0086-021-25070765
Email
wuyuz@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
12. IPD Sharing Statement
Learn more about this trial
Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
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