Back to resultsHepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hepatectomy combined with lymphadenectomy
hepatectomy alone
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, hepatectomy, lymphadenectomy, complication, prognosis
Eligibility Criteria
Inclusion Criteria:
- age 18 to 65 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
- good liver function with Pugh-Child Class A or B;
- indocyanine green retention at 15 minutes (ICG-R15) <15%;
- without severe cirrhosis;
- the diameter of tumor is equal to or more than 3 cm;
- the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
- absence of extrahepatic metastasis.
Exclusion Criteria:
- the diameter of tumor is less than 3 cm;
- palliative resection of tumor;
- with the history of hepatic encephalopathy, ascites, and variceal bleeding;
- with severe hepatic cirrhosis;
- tumor rupture;
- with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hepatectomy combined lymphadenectomy
hepatectomy
Arm Description
hepatectomy combined lymphadenectomy
hepatectomy alone
Outcomes
Primary Outcome Measures
Recurrence-free survival
The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.
Secondary Outcome Measures
Post-operation complication
Full Information
NCT ID
NCT02031952
First Posted
January 4, 2014
Last Updated
January 8, 2014
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02031952
Brief Title
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
Official Title
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.
This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, hepatectomy, lymphadenectomy, complication, prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hepatectomy combined lymphadenectomy
Arm Type
Experimental
Arm Description
hepatectomy combined lymphadenectomy
Arm Title
hepatectomy
Arm Type
Active Comparator
Arm Description
hepatectomy alone
Intervention Type
Procedure
Intervention Name(s)
hepatectomy combined with lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
hepatectomy alone
Primary Outcome Measure Information:
Title
Recurrence-free survival
Description
The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Post-operation complication
Time Frame
90-d after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 to 65 years;
Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
good liver function with Pugh-Child Class A or B;
indocyanine green retention at 15 minutes (ICG-R15) <15%;
without severe cirrhosis;
the diameter of tumor is equal to or more than 3 cm;
the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
absence of extrahepatic metastasis.
Exclusion Criteria:
the diameter of tumor is less than 3 cm;
palliative resection of tumor;
with the history of hepatic encephalopathy, ascites, and variceal bleeding;
with severe hepatic cirrhosis;
tumor rupture;
with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunfei Yuan, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
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