Hepatocellular CarcinomaNCT01713244
Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma
A study testing RFA assisted Hepatectomy and Hepatectomy in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- RFA assisted Hepatectomy and Hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Nov 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
- Diagnosis of HCC confirmed at our hospital.
- Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
- Liver function of Child-Pugh Class A or B.
- Tumors lacked intrahepatic and extrahepatic metastasis.
- Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
- Indocyanine green retention at 15 minutes (ICG-15) of <10%.
- No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds.
- No other anti-tumor therapy received before the treatment. -
Who cannot join
- Patients met the inclusion criteria but declined to participate.
- Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
- Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Kai Feng, M.D, +86-23-13228683383, fengkai7688@hotmail.com
Kai Feng, M.D
About this study
Official title: A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma
RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- RFA assisted Hepatectomy, Hepatectomy
- Keywords
- Hepatocellular Carcinoma, Radiofrequency Ablation, Hepatectomy, Recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA assisted HepatectomyProcedure or surgery
Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.
HepatectomyProcedure or surgery
Treat the advanced HCC with the hepatectomy only.
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy | Active comparator | Using Hepatectomy for the treatment of advanced HCC Receives: Procedure: Hepatectomy |
| RFA assisted Hepatectomy | Experimental | Ablating the liver tissue around the tumor before hepatectomy. Receives: Procedure: RFA assisted Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival
Measured: 2 years
Secondary outcomes (1)
Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fengkai, Southwest Hospital, China
- Investigators
- Kuansheng Ma, Ph.D, Study director, Institute of hepatobiliary surgery,Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713244
- Sponsor's protocol ID
- SKLKF201209
- Status last verified
- Nov 2015
- First submitted
- 21 Oct 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01713244
- Acronym / sponsor ID
- SKLKF201209
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Radiofrequency Ablation, Hepatectomy, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 24 Oct 2012 (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.
RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy | Active comparator | Procedure: HepatectomyUsing Hepatectomy for the treatment of advanced HCC |
| RFA assisted Hepatectomy | Experimental | Procedure: RFA assisted HepatectomyAblating the liver tissue around the tumor before hepatectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of HCC confirmed at our hospital.
- Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
- Liver function of Child-Pugh Class A or B.
- Tumors lacked intrahepatic and extrahepatic metastasis.
- Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
Key exclusion criteria (3 listed)
- Patients met the inclusion criteria but declined to participate.
- Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
- Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
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 |
|---|---|---|
| RFA assisted HepatectomyUsing RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell. | Procedure or surgery | RFA assisted Hepatectomy |
| HepatectomyTreat the advanced HCC with the hepatectomy only. | Procedure or surgery | Hepatectomy |
Primary outcome
Recurrence-free Survival
Time frame: 2 years
1 secondary outcome
Overall Survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Kuansheng Ma, Ph.D study director
Institute of hepatobiliary surgery,Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA assisted Hepatectomy and Hepatectomy in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 1 site 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 8 inclusion and 3 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Kai Feng, M.D (+86-23-13228683383, fengkai7688@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (time frame: 2 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 20 Nov 2015.