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Percutaneous Radiofrequency Ablation Versus Repeat Hepatectomy for Recurrent Hepatocellular Carcinoma


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Percutaneous Radiofrequency Ablation Versus Repeat Hepatectomy for Recurrent Hepatocellular Carcinoma


Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial
hepatectomy is still considered as the conventional therapy for HCC. Intrahepatic recurrence
of HCC after partial hepatectomy is common and was reported to be more than 77% within 5
years after surgery. Repeat hepatectomy is an effective treatment for intrahepaticHCC
recurrence, with a 5-year survival rate of 19.4-56%. This is comparable to the survival
after initial hepatectomy for HCC. Unfortunately, repeat hepatectomy could be carried out
only in a small proportion of patients with HCC recurrence (10.4-31%), either because of the
poor functional liver reserve or because of widespread intrahepatic recurrence. In the past
two decades, percutaneous radiofrequency ablation (PRFA) has emerged as a new treatment
modality and has attracted great interest because of its effectiveness and safety for small
HCC (≤ 5.0 cm). Studies using PRFA to treat recurrent HCC after partial hepatectomy reported
a 3-year survival rate of 62-68%, which is comparable to those achieved by surgery. PRFA is
particularly suitable to treat recurrent HCC after partial hepatectomy because these tumors
are usually detected when they are small and PRFA causes the least deterioration of liver
function in the patients. To the best of our knowledge, there has been no report published
in the medical literature comparing the efficacy of repeat hepatectomy with PRFA for
recurrent HCC. The aim of this retrospective study is to compare the outcome of repeat
hepatectomy with PRFA for small recurrent HCC after partial hepatectomy.


Inclusion Criteria:



1. age 18 - 75 years;

2. Distant recurrence of HCC after initial curative treatment (including initial RFA or
hepatectomy);

3. no other treatment received except for the initial RFA or hepatectomy;

4. Single tumor less than 4cm in diameter;

5. lesions visible on ultrasound and with an acceptable and safe path between the lesion
and the skin as shown on ultrasound;

6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of <
40,000 / mm3;

7. Eastern Co-operative Oncology Group performance(ECOG) status 0 -

Exclusion Criteria:

1. the presence of vascular invasion or extrahepatic spread on imaging;

2. a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including
ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count
of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic
encephalopathy;

3. an American Society of Anesthesiologists (ASA) score ≥ 3

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

5-year

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

HCC16

NCT ID:

NCT01570166

Start Date:

November 2011

Completion Date:

June 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • RFA
  • HR
  • Carcinoma
  • Carcinoma, Hepatocellular

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