Hepatocellular CarcinomaNCT02830737
No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma
A study testing Traditional RFA and No-touch RFA in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an electrode needle directly into the tumor. This clearly violates no-touch technique based on the principle of surgical oncology. 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?
- Traditional RFA and No-touch RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2020
- 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
- Primary hepatocellular carcinoma, according to the postoperative pathological examination as the standard, or the diagnostic criteria with reference to the 2012 American Association for the Study of Liver Diseases if the pathological evidence is not available;
- A single tumor with a diameter ≤3cm;
- The tumor that has not invaded the portal vein, the hepatic vein, or the secondary branch;
- Liver function classified as Child A or B;
- Liver reserve function test with ICG-R15 (indocyanine green retention at 15min) ≤30%, and the important organs that can function with the tolerance of RFA or partial hepatectomy;
- No significant coagulopathy: platelet count > 50,000,000,000 /L, prolonged prothrombin time < 5 seconds;
- Age 18 - 70 years old;
- No acceptance of other anti-cancer therapy before the treatment.
Who cannot join
- Complication of severe portal hypertension: a history of upper gastrointestinal bleeding, a history of severe hypersplenism, or refractory ascites;
- Patients with extrahepatic metastasis or lymph node metastasis;
- Patients with multiple liver tumors found from imaging exam or during the treatment;
- Patients with pathological examinations showing the other tissue type of liver cancer after the treatment;
- Patients who expect to receive a liver transplant;
- Patients whose preoperative imaging exam indicates the tumor close to the gallbladder, hilar major blood vessels, bile ducts and surrounding vital organs, with a potential of serious injury by mistake or serious complications during the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038
About this study
Official title: Prospective Randomized Comparative Study on No-touch Radiofrequency Ablation Treatment of Small Hepatocellular Carcinoma
Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an electrode needle directly into the tumor. This clearly violates no-touch technique based on the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to 30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA treatment reduce the recurrence rate after operation in comparison with the traditional RFA treatment. This research project aims at using the prospective randomized comparative method to compare the short-term and the long-term curative effects between no-touch RFA and traditional RFA treatments for small hepatic carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Traditional RFA, No-touch RFA
- Keywords
- Small Hepatocellular Carcinoma, No-touch RFA, Traditional RFA, Recurrence rate
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional RFAProcedure or surgery
Also called RFA
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center
No-touch RFAProcedure or surgery
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the tumor-free zone (within 5mm along the edge of the tumor)
| Study group | Role | What they receive |
|---|---|---|
| Traditional RFA | Active comparator | Using Traditional RFA for the treatment of small hepatocellular carcinoma Receives: Procedure: Traditional RFA |
| No-touch RFA | Experimental | Using No-touch RFA for the treatment of small hepatocellular carcinoma Receives: Procedure: No-touch RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
Measured: 3 years
Secondary outcomes (2)
Recurrence-free Survival Rate
Measured: 3 years
Overall Survival Rate
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 posted13 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (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
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuelong Chai, Southwest Hospital, China
- Investigators
- Ma Kuansheng, Ph.D, Study director, Institute of hepatobiliary surgery,Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830737
- Sponsor's protocol ID
- SWH2015LC02
- Status last verified
- Sep 2017
- First submitted
- 5 Jul 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparative Study on No-touch Radiofrequency Ablation Treatment of Small Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02830737
- Acronym / sponsor ID
- SWH2015LC02
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Small Hepatocellular Carcinoma, No-touch RFA, Traditional RFA, Recurrence rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jul 2016 (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.
Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an electrode needle directly into the tumor. This clearly violates no-touch technique based on the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to 30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA treatment reduce the recurrence rate after operation in comparison with the traditional RFA treatment. This research project aims at using the prospective randomized comparative method to compare the short-term and the long-term curative effects between no-touch RFA and traditional RFA treatments for small hepatic carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional RFA | Active comparator | Procedure: Traditional RFAUsing Traditional RFA for the treatment of small hepatocellular carcinoma |
| No-touch RFA | Experimental | Procedure: No-touch RFAUsing No-touch RFA for the treatment of small hepatocellular carcinoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary hepatocellular carcinoma, according to the postoperative pathological examination as the standard, or the diagnostic criteria with reference to the 2012 American Association for the Study of Liver Diseases if the pathological evidence is not available;
- A single tumor with a diameter ≤3cm;
- The tumor that has not invaded the portal vein, the hepatic vein, or the secondary branch;
- Liver function classified as Child A or B;
- Liver reserve function test with ICG-R15 (indocyanine green retention at 15min) ≤30%, and the important organs that can function with the tolerance of RFA or partial hepatectomy;
Key exclusion criteria (6 listed)
- Complication of severe portal hypertension: a history of upper gastrointestinal bleeding, a history of severe hypersplenism, or refractory ascites;
- Patients with extrahepatic metastasis or lymph node metastasis;
- Patients with multiple liver tumors found from imaging exam or during the treatment;
- Patients with pathological examinations showing the other tissue type of liver cancer after the treatment;
- Patients who expect to receive a liver transplant;
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 |
|---|---|---|
| Traditional RFAAlso: RFARadio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center | Procedure or surgery | Traditional RFA |
| No-touch RFARadio frequency ablation via an ultrasound-guided electrode needle penetrating into the tumor-free zone (within 5mm along the edge of the tumor) | Procedure or surgery | No-touch RFA |
Primary outcome
Recurrence Rate
Time frame: 3 years
2 secondary outcomes
Recurrence-free Survival Rate
Time frame: 3 years
Overall Survival Rate
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 15 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ma Kuansheng, 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 Traditional RFA and No-touch RFA 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 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 15 Sep 2017. 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?
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?
Recurrence Rate (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 15 Sep 2017.