Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Recurrence-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Recurrence-free survival
Time Frame: 5 year
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 Outcomes
- Post-operation complication(90-d after surgery)
Investigators
Yunfei Yuan
Professor
Sun Yat-sen University