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A Prospective Randomized Trial of Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma Complicating Clinically Significant Portal Hypertension Within the Milan Criteria


N/A
18 Years
70 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma With CSPH

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Trial Information

A Prospective Randomized Trial of Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma Complicating Clinically Significant Portal Hypertension Within the Milan Criteria


HCC is a major health problem worldwide, with an estimated incidence ranging between 500,000
and 1,000,000 new cases annually. It is the fifth most common cancer in the world and the
third most common cause of cancer-related death,especially in East-Asia countries.SR remains
the first therapeutic option for a cure but is suitable only for 9%—27% of patients.The
presence of significant background cirrhosis often precludes liver resection for HCC.Even
though these HCC patients undergo SR,the incidence of posthepatectomy liver failure(PHLF)
and death would be high,especially to HCC patients complicating CSPH,whose corresponding
risk of PHLF and persistent PHLF were 59.02%and 14.75%respectively in our past study. It is
extremely urgent to search a safe and effective means in this subgroup of HCC
patients.PLAT, a recently developed local ablative technique, has attracted the greatest
interest and popularity because of its effectiveness and safety,with a 3-year survival rate
of 62-77%,a low treatment complication rate of 8-9% and a low treatment mortality rate of
0-0.5%.However, there is still debate on whether PLAT or SR is the most suitable therapy for
HCC.To our knowledge,there have been no study on the therapy of HCC complicating CSPH.


Inclusion Criteria:



1. 18 Years < ge ≤ 70 Y,KPS ≥ 70

2. A solitary HCC ≤ 5cm in diameter,or multiple HCC(≤3) ,each ≤3cm in diameter without
evidence of radiologically definable vascular invasion or extrahepatic metastasis.
allowing to both SR and PLAT

3. Child-Pugh class A or B,without history of encephalopathy,ascites refractory to
diuretics,or variceal bleeding

4. NO previous treatment of HCC

5. Platelet count>40,000/mm3;prothrombin time prolongation of no more than 3 seconds

6. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

1. metastatic liver cancer

2. Patients with apparent cardiac,pulmonary,cerebral and renal dysfunction,which may
affect the treatment of HCC

3) Patients with other diseases which may affect the treatment mentioned

4) Patients participating in other clinical trials

5) Patients with a medical history of other malignant tumors

6) Pregnant and breast-feeding women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

EHBHKY2012-002-12

NCT ID:

NCT01860222

Start Date:

January 2011

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma With CSPH
  • Hepatocellular carcinoma
  • CSPH
  • Hepatectomy
  • percutaneous local ablative
  • therapy (PLAT)
  • randomized controlled trials(RCTs)
  • Carcinoma
  • Hypertension, Portal
  • Carcinoma, Hepatocellular

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