Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC

Phase 4

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT02535117
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to the lack of donors Recurrence of tumor within the liver remnant is also common, with a reported 5-year recurrence rate of 50-70%, in patients who have undergone "curative" hepatectomy. Management of recurrent HCC is still urgent and several treatments have been developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a 5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients with HCC recurrence due to the poor functional liver reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after treatment, radiofreqency ablation (RFA) has been used as an effective treatment for recurrent HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery. Laparoscopic surgery was considered not to be a suitable treatment for recurrent HCC due to postoperative adhesions that can make laparoscopic surgical procedure more difficult and less safe. Recently, several studies reported that laparoscopic surgery for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. By far, no study has been performed to compare the efficacy and safety of laparoscopic surgery with RFA for treatment of recurrent HCC.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-25
• Last Update Submitted: 2015-08-25
• Study First Posted: 2015-08-28
• Last Update Posted: 2015-08-28
• Primary Completion: 2018-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 216

Inclusion Criteria

1. age 18-75 years;
2. recurrent HCC after curative partial hepatectomy;
3. no other treatment received except for partial hepatectomy;
4. a solitary recurrent HCC ≤ 5.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
5. no radiologic evidence of invasion into major portal/ hepatic vein branches ;
6. no extrahepatic metastases;
7. Child-pugh class A or B liver cirrhosis;
8. American Society of Anesthesiologists (ASA) score ≤ 3;
9. Eastern Co-operative Oncology Group performance (ECOG) status 0;

Exclusion Criteria

1. coagulation disorders (prothrombin activity <40% or a platelet count of <80,000/mm3);
2. Child-Pugh class C liver cirrhosis;
3. history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
4. a history of a secondary malignancy;
5. active infection (except viral hepatitis);
6. severe dysfunction of the heart, kidney, or other organs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	1 month
Recurrence-free survival	5 years