Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma With CSPH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01860222
• Other study ID #: EHBHKY2012-002-12
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2013
• Last updated: March 30, 2016
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the operative complication and short-/long-term therapeutic effects of percutaneous local ablative therapy (PLAT) versus surgical resection(SR) on small hepatocellular carcinoma(HCC) patients with clinically significant portal hypertension(CSPH) so as to lend clinical and theoretical basis of the therapeutic schemes for the disease.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma With CSPH

Intervention

Procedure:
• SR

• PLAT

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai
China	Eastern Hepatobiliary Surgery Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years	No
Secondary	local tumor progression		3 years	No