Clinical trial NCT02785380: Laparoscopic Surgery VS RFA for Recurrent HCC
Official title: Laparoscopic Surgery Versus Radiofrequency Ablation for the Treatment of Recurrent Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Second Military Medical University
First posted: 2016-05-27
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of recurrent HCC is urgent and several treatments have been developed .Repeat hepatectomy is considered to be the first choice for recurrent HCC.

Unfortunately, repeated open hepatectomy can be performed only in a small proportion of patients due to inadequate liver function reserve, widespread recurrence or high invasiveness. Given that recurrent tumors are usually detected at small size during follow-up after initial surgery, radiofreqency ablation (RFA), which is less invasive, may be locally curative and causes minimal damage to liver function reserve,has been widely used. However, the re-recurrence rate after RFA is more than 50%,and the recurrence-free survival is less than 20%. Recently, satisfactory short- and long-term oncological outcomes have been reported for laparoscopic surgery (LS) for the treatment for primary HCC with cirrhosis. Some single center pilot studies reported that LS may, compared with open surgery, improve the prognosis of HCC with less blood loss and shorter hospital stay. LS was initially considered not suitable for recurrent HCC due to postoperative adhesions that might make laparoscopic surgical procedure more difficult and less safe. With improvement in technique and experience, recent studies showed that LS for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. However, thus far, no study has been performed to evaluate the long-term oncological outcomes of LS for recurrent HCC, and compare those results to that for RFA. To clarify these issues, a multicenter retrospective comparative study by using propensity score matching method that included a large consecutive series of patients with recurrent HCC within Milan criteria, who underwent LS or RFA, was performed.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years;
2. First recurrent HCC after curative hepatectomy;
3. A solitary recurrent HCC ≤ 3.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
4. Tumor located in left lateral lobe (segment II or III) or subcapsule of liver(subcapsular nodule was defined as a lesion located less than 1 cm from the liver edge and could be treated by either LS or RFA.
5. No radiologic evidence of invasion into major portal/ hepatic vein branches;
6. No extrahepatic metastases;
7. Child-Turcotte-Pugh class A or B;

Exclusion Criteria:

1. Coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3);
2. History of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
3. History of a secondary malignancy;
4. 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
Other outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by
timeFrame: 1 month
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camma C, Di Marco V, Orlando A, Sandonato L, Casaril A, Parisi P, Alizzi S, Sciarrino E, Virdone R, Pardo S, Di Bona D, Licata A, Latteri F, Cabibbo G, Montalto G, Latteri MA, Nicoli N, Craxi A; Unita Interdipartimentale Neoplasie Epatiche (U.I.N.E) Group. Treatment of hepatocellular carcinoma in compensated cirrhosis with radio-frequency thermal ablation (RFTA): a prospective study. J Hepatol. 2005 Apr;42(4):535-40. doi: 10.1016/j.jhep.2004.11.042.
citation: Poon RT, Fan ST, Lo CM, Liu CL, Wong J. Intrahepatic recurrence after curative resection of hepatocellular carcinoma: long-term results of treatment and prognostic factors. Ann Surg. 1999 Feb;229(2):216-22. doi: 10.1097/00000658-199902000-00009.