Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma
A Prospective Randomized Trial of Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma Complicating Clinically Significant Portal Hypertension Within the Milan Criteria
1 other identifier
interventional
160
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 31, 2016
March 1, 2016
2.9 years
May 15, 2013
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
3 years
Secondary Outcomes (1)
local tumor progression
3 years
Study Arms (2)
SR
ACTIVE COMPARATORPLAT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Years \< ge ≤ 70 Y,KPS ≥ 70
- 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
- Child-Pugh class A or B,without history of encephalopathy,ascites refractory to diuretics,or variceal bleeding
- NO previous treatment of HCC
- Platelet count\>40,000/mm3；prothrombin time prolongation of no more than 3 seconds
- Patients who can understand this trial and have signed information consent
You may not qualify if:
- metastatic liver cancer
- Patients with apparent cardiac,pulmonary,cerebral and renal dysfunction,which may affect the treatment of HCC
- \) Patients with other diseases which may affect the treatment mentioned
- ） Patients participating in other clinical trials
- ） Patients with a medical history of other malignant tumors
- \) Pregnant and breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice president of the Eastern Hepatobiliary Surgery Hospital
Study Record Dates
First Submitted
May 15, 2013
First Posted
May 22, 2013
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2016
Last Updated
March 31, 2016
Record last verified: 2016-03