Carcinoma, HepatocellularNCT02482909
A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma
A study testing Hepatic resection and Radiofrequency ablation in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital.
Trial summary
The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Hepatic resection and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Jul 2013
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 70 years
- Child-Pugh class A (score 5-6)
- Single hepatocellular carcinoma
- Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)
- No previous treatment
- Platelet count > 80,000/mm3
Who cannot join
- HCC abutting main hepatic veins or the first branches of the main portal vein
- HCC abutting vessels ≥ 0.5 cm
About this study
Official title: A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma
The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Hepatic resection, Radiofrequency ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic resectionProcedure or surgery
Anatomical surgical resection of the liver including the tumor
Radiofrequency ablationProcedure or surgery
Percutaneous ablation using radiofrequency under the imaging guidance
| Study group | Role | What they receive |
|---|---|---|
| Hepatic resection | Experimental | Hepatic resection is performed as a primary treatment for hepatocellular carcinoma. Receives: Procedure: Hepatic resection |
| Radiofrequency ablation | Experimental | Radiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient survival
Measured: From the intervention up to 5 years or until the death of the participant whichever came first
Secondary outcomes (1)
The disease-free survival
Measured: From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJul 2005
- Primary completionMay 2013
- Study completionJul 2013
Why it stopped: The post-treatment recurrence rate was expected to be different between two treatment groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea
- Responsible party
- Principal investigator, Kyung-Suk Suh, Seoul National University Hospital
- Investigators
- Kyung-Suk Suh, ME, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482909
- Sponsor's protocol ID
- 0520090
- Status last verified
- Jun 2015
- First submitted
- 20 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02482909
- Acronym / sponsor ID
- 0520090
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The post-treatment recurrence rate was expected to be different between two treatment groups.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea
- Study start
- Jul 2005
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jun 2015 (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 purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatic resection | Experimental | Procedure: Hepatic resectionHepatic resection is performed as a primary treatment for hepatocellular carcinoma. |
| Radiofrequency ablation | Experimental | Procedure: Radiofrequency ablationRadiofrequency ablation is performed as a primary treatment for hepatocellular carcinoma. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 20 and 70 years
- Child-Pugh class A (score 5-6)
- Single hepatocellular carcinoma
- Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)
- No previous treatment
Key exclusion criteria (2 listed)
- HCC abutting main hepatic veins or the first branches of the main portal vein
- HCC abutting vessels ≥ 0.5 cm
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 |
|---|---|---|
| Hepatic resectionAnatomical surgical resection of the liver including the tumor | Procedure or surgery | Hepatic resection |
| Radiofrequency ablationPercutaneous ablation using radiofrequency under the imaging guidance | Procedure or surgery | Radiofrequency ablation |
Primary outcome
The patient survival
Time frame: From the intervention up to 5 years or until the death of the participant whichever came first
1 secondary outcome
The disease-free survival
Time frame: From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first
Results and safety
The study was stopped early (reason given: The post-treatment recurrence rate was expected to be different between two treatment groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Kyung-Suk Suh, ME, PhD study director
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hepatic resection and Radiofrequency ablation in people with Carcinoma, Hepatocellular, run by Seoul National University Hospital.
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 2 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: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: The post-treatment recurrence rate was expected to be different between two treatment groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient survival (time frame: From the intervention up to 5 years or until the death of the participant whichever came first). 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 26 Jun 2015.