- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860222
Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma
March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital
A Prospective Randomized Trial of Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma Complicating Clinically Significant Portal Hypertension Within the Milan Criteria
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Shanghai, China
- Recruiting
- Eastern Hepatobiliary Surgery Hospital
-
Contact:
- wu dong, MD
- Phone Number: 0086-021-81875532
- Email: wuyuz@aliyun.com
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Contact:
- qu shuping, doctor
- Phone Number: 0086-021-81875533
- Email: shupingqu33@sina.com
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Principal Investigator:
- wu dong, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- metastatic liver cancer
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SR
|
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Experimental: PLAT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
local tumor progression
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
May 15, 2013
First Submitted That Met QC Criteria
May 21, 2013
First Posted (Estimate)
May 22, 2013
Study Record Updates
Last Update Posted (Estimate)
March 31, 2016
Last Update Submitted That Met QC Criteria
March 30, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EHBHKY2012-002-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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