Laparoscopic HepatectomyNCT01471080
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver
A study testing RFA and hepatectomy in people with Laparoscopic Hepatectomy and Radio-frequency Ablation, run by Southwest Hospital, China at 1 site in China.
Trial summary
In the past, the investigators often treated giant cavernous hemangiomas of the liver by hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied to cure this disease.But we can't get a clear answer about their effectiveness and safety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Hepatectomy, Radio-frequency Ablation, Giant Cavernous Hemangiomas
- What is being tested?
- RFA and hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Jan 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- giant cavernous hemangiomas with a diameter larger than or equal to 5 cm diagnosed by more than one imaging modalities
- age between 18 years to 65 years
- without gender restriction
- PLT account more than 50 e9
- without abnormal of liver function test
- with substantial evidence of growing size than before
- symptom associated cavernous hemangiomas
- with a strong desire of the patients for the treatment
Who cannot join
- pregnant women
- abnormal of liver function or coagulation dysfunction and/or concurrent with sever cardiac or pulmonary disorders
- patient with a poor condition that can't bear the approach of either RFA or laparoscopic hepatectomy
- tumor size more than 20cm
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: A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.
In the past, the investigators often treated giant cavernous hemangiomas of the liver by hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied to cure this disease.But we can't get a clear answer about their effectiveness and safety. Hence the investigators conduct this study to explore the effectiveness and efficiency of the these two methods and compare their short to mid-term outcomes.
- Being tested
- RFA, hepatectomy
- Keywords
- laparoscopic hepatectomy, radio-frequency ablation, giant cavernous hemangiomas, liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
Also called radiofrequence ablation
using RFA to treat cavernous hemangiomas
hepatectomyProcedure or surgery
Also called liver resection
using hepatectomy to treat cavernous hemangiomas
| Study group | Role | What they receive |
|---|---|---|
| RFA group | Experimental | using RFA to treat cavernous hemangiomas Receives: Procedure: RFA |
| hepatectomy group | Active comparator | using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver Receives: Procedure: hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disappearance rate of disease
to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT
Measured: 1 month
Secondary outcomes (2)
complication rate
obvious complications including bleeding, bile leakage will be take into account.recover rate. symptom relief and satisfactory of the treatment
Measured: 1 month
hospital stay and relating overall cost for treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HepatectomyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471080
- Sponsor's protocol ID
- swhb004
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2011
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.
- ClinicalTrials.gov ID
- NCT01471080
- Acronym / sponsor ID
- swhb004
- Keywords
- laparoscopic hepatectomy, radio-frequency ablation, giant cavernous hemangiomas, liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Nov 2011 (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.
In the past, the investigators often treated giant cavernous hemangiomas of the liver by hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied to cure this disease.But we can't get a clear answer about their effectiveness and safety. Hence the investigators conduct this study to explore the effectiveness and efficiency of the these two methods and compare their short to mid-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA group | Experimental | Procedure: RFAusing RFA to treat cavernous hemangiomas |
| hepatectomy group | Active comparator | Procedure: hepatectomyusing laparoscopic hepatectomy to treat cavernous hemangiomas of the liver |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- giant cavernous hemangiomas with a diameter larger than or equal to 5 cm diagnosed by more than one imaging modalities
- age between 18 years to 65 years
- without gender restriction
- PLT account more than 50 e9
- without abnormal of liver function test
Key exclusion criteria (4 listed)
- pregnant women
- abnormal of liver function or coagulation dysfunction and/or concurrent with sever cardiac or pulmonary disorders
- patient with a poor condition that can't bear the approach of either RFA or laparoscopic hepatectomy
- tumor size more than 20cm
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 |
|---|---|---|
| RFAAlso: radiofrequence ablationusing RFA to treat cavernous hemangiomas | Procedure or surgery | RFA group |
| hepatectomyAlso: liver resectionusing hepatectomy to treat cavernous hemangiomas | Procedure or surgery | hepatectomy group |
Primary outcome
disappearance rate of disease
Time frame: 1 month
to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT
2 secondary outcomes
complication rate
Time frame: 1 month
hospital stay and relating overall cost for treatment
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and hepatectomy in people with Laparoscopic Hepatectomy and Radio-frequency Ablation, 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 4 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: finished, as of the sponsor's last update on 2 Jul 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disappearance rate of disease (time frame: 1 month). 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 2 Jul 2014.