Clinical trial NCT02535117: Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC
Official title: Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Initial Partial Hepatectomy: A Multicenter Experience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 216
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 5 years
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belli G, Fantini C, D'Agostino A, Cioffi L, Langella S, Russolillo N, Belli A. Laparoscopic versus open liver resection for hepatocellular carcinoma in patients with histologically proven cirrhosis: short- and middle-term results. Surg Endosc. 2007 Nov;21(11):2004-11. doi: 10.1007/s00464-007-9503-6. Epub 2007 Aug 19.
citation: Peng ZW, Zhang YJ, Liang HH, Lin XJ, Guo RP, Chen MS. Recurrent hepatocellular carcinoma treated with sequential transcatheter arterial chemoembolization and RF ablation versus RF ablation alone: a prospective randomized trial. Radiology. 2012 Feb;262(2):689-700. doi: 10.1148/radiol.11110637. Epub 2011 Dec 12.