Hepatocellular Carcinoma With CSPHNCT01860222
Surgical Resection Versus Percutaneous Local Ablative Therapy for Hepatocellular Carcinoma
A study testing SR and PLAT in people with Hepatocellular Carcinoma With CSPH, run by Eastern Hepatobiliary Surgery Hospital at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma With CSPH
- What is being tested?
- SR and PLAT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai
wu dong, MD, 0086-021-81875532, wuyuz@aliyun.com
qu shuping, doctor, 0086-021-81875533, shupingqu33@sina.com
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai
wu dong, MD, 0086-021-81875532, wuyuz@aliyun.com
qu shuping, doctor, 0086-021-81875533, shupingqu33@sina.com
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma With CSPH
- Being tested
- SR, PLAT
- Keywords
- Hepatocellular carcinoma, CSPH, Hepatectomy, percutaneous local ablative, therapy (PLAT), randomized controlled trials(RCTs)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRProcedure or surgery
PLATProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SR | Active comparator | Not described Receives: Procedure: SR |
| PLAT | Experimental | Not described Receives: Procedure: PLAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
Secondary outcomes (1)
local tumor progression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma With CSPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860222
- Sponsor's protocol ID
- EHBHKY2012-002-12
- Status last verified
- Mar 2016
- First submitted
- 15 May 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01860222
- Acronym / sponsor ID
- EHBHKY2012-002-12
- Conditions
- Hepatocellular Carcinoma With CSPH
- Keywords
- Hepatocellular carcinoma, CSPH, Hepatectomy, percutaneous local ablative, therapy (PLAT), randomized controlled trials(RCTs)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR | Active comparator | Procedure: SR |
| PLAT | Experimental | Procedure: PLAT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR | Procedure or surgery | SR |
| PLAT | Procedure or surgery | PLAT |
Primary outcome
overall survival
Time frame: 3 years
1 secondary outcome
local tumor progression
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SR and PLAT in people with Hepatocellular Carcinoma With CSPH, run by Eastern Hepatobiliary Surgery Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.