Hepatic HemangiomaNCT07919860
Observation Study on the Efficacy and Safety of Hepatic Artery Embolization Combined With Radiofrequency Ablation for Hepatic Hemangioma: The Impact of Different Treatment Intervals
An observational study of Hepatic Hemangioma, run by Beijing Tiantan Hospital.
Trial summary
The goal of this observational study is to learn about the efficacy-safety profiles of combined hepatic arterial embolization (TAE) and laparoscopic radiofrequency ablation (RFA) in patients with hepatic hemangioma who receive sequential TAE-RFA treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Hemangioma
- What is being tested?
- transcatheter arterial embolization (TAE) and radiofrequency ablation (RFA)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-80 years with hepatic hemangioma >5 cm, eligible for transarterial embolization (TAE), and with acceptable liver function reserve. Patients with contrast allergy or anesthesia contraindications are excluded. Enrolled participants are stratified into two cohorts according to the time interval between TAE and subsequent laparoscopic radiofrequency ablation (RFA): short-interval group (10-14 days after TAE) and long-interval group (2-3 months after TAE).
Inclusion Criteria: Age 18-80 years; definite HH diagnosis via abdominal imaging with diameter > 5 cm; identifiable feeding artery suitable for embolization; preserved hepatic reserve without severe pre-existing liver disease; no contrast media allergy; no surgical anesthesia contraindications; subjects understand procedural risks and are willing for study participation.
- Exclusion Criteria: Uncertain HH diagnosis where other solid hepatic lesions cannot be excluded; hepatic insufficiency, liver cirrhosis, ascites, hepatic encephalopathy; concurrent active anti malignant tumor therapy for hepatic or extra hepatic neoplasms; contrast media allergy or severe cardiopulmonary cerebrovascular diseases precluding procedural tolerance; pregnant or lactating women, patients with pregnancy planning requirements; refusal of study participation after adequate information disclosure.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn about the efficacy-safety profiles of combined hepatic arterial embolization (TAE) and laparoscopic radiofrequency ablation (RFA) in patients with hepatic hemangioma who receive sequential TAE-RFA treatment. The main question it aims to answer is: Does the time interval between TAE and subsequent RFA influence therapeutic efficacy and safety in patients with hepatic hemangioma receiving sequential TAE-RFA therapy? Participants already undergoing TAE followed by RFA as part of their regular clinical management for hepatic hemangioma will undergo scheduled laboratory tests and contrast-enhanced abdominal CT examinations over a 12-month follow-up period.
- Conditions
- Hepatic Hemangioma
- Being tested
- transcatheter arterial embolization (TAE), radiofrequency ablation (RFA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter arterial embolization (TAE)Procedure or surgery
Right femoral artery access; embolic agents: gelatin sponge particles combined with lipiodol; procedural endpoint: cessation of lipiodol inflow into hemangioma lesion
radiofrequency ablation (RFA)Procedure or surgery
Laparoscopic radiofrequency ablation to facilitate intra operative bleeding surveillance and ablation zone assessment. Hepatic inflow occlusion will be performed for lesions >10 cm
| Study group | Role | What they receive |
|---|---|---|
| Short-interval group | RFA is performed at 10-14 days after TAE Receives: Procedure: transcatheter arterial embolization (TAE); Procedure: radiofrequency ablation (RFA) | |
| Long-interval group | RFA is performed at 2-3 months after TAE Receives: Procedure: transcatheter arterial embolization (TAE); Procedure: radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour volume reduction rate
Measured: 6 month and 12 month post RFA
Secondary outcomes (1)
Peri-procedural complication incidence
Measured: day 1 post TAE and day 1 / day 4 post RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic HemangiomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919860
- Sponsor's protocol ID
- BTHospitalPW
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study on the Efficacy and Safety of Hepatic Artery Embolization Combined With Radiofrequency Ablation for Hepatic Hemangioma: The Impact of Different Treatment Intervals
- ClinicalTrials.gov ID
- NCT07919860
- Acronym / sponsor ID
- BTHospitalPW
- Conditions
- Hepatic Hemangioma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Nov 2026 (actual)
- 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 goal of this observational study is to learn about the efficacy-safety profiles of combined hepatic arterial embolization (TAE) and laparoscopic radiofrequency ablation (RFA) in patients with hepatic hemangioma who receive sequential TAE-RFA treatment. The main question it aims to answer is: Does the time interval between TAE and subsequent RFA influence therapeutic efficacy and safety in patients with hepatic hemangioma receiving sequential TAE-RFA therapy? Participants already undergoing TAE followed by RFA as part of their regular clinical management for hepatic hemangioma will undergo scheduled laboratory tests and contrast-enhanced abdominal CT examinations over a 12-month follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-interval group | – | Procedure: transcatheter arterial embolization (TAE), Procedure: radiofrequency ablation (RFA)RFA is performed at 10-14 days after TAE |
| Long-interval group | – | Procedure: transcatheter arterial embolization (TAE), Procedure: radiofrequency ablation (RFA)RFA is performed at 2-3 months after TAE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 years with hepatic hemangioma >5 cm, eligible for transarterial embolization (TAE), and with acceptable liver function reserve. Patients with contrast allergy or anesthesia contraindications are excluded. Enrolled participants are stratified into two cohorts according to the time interval between TAE and subsequent laparoscopic radiofrequency ablation (RFA): short-interval group (10-14 days after TAE) and long-interval group (2-3 months after TAE).
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 |
|---|---|---|
| transcatheter arterial embolization (TAE)Right femoral artery access; embolic agents: gelatin sponge particles combined with lipiodol; procedural endpoint: cessation of lipiodol inflow into hemangioma lesion | Procedure or surgery | Long-interval group, Short-interval group |
| radiofrequency ablation (RFA)Laparoscopic radiofrequency ablation to facilitate intra operative bleeding surveillance and ablation zone assessment. Hepatic inflow occlusion will be performed for lesions >10 cm | Procedure or surgery | Long-interval group, Short-interval group |
Primary outcome
Tumour volume reduction rate
Time frame: 6 month and 12 month post RFA
1 secondary outcome
Peri-procedural complication incidence
Time frame: day 1 post TAE and day 1 / day 4 post RFA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Hemangioma, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Xing (+86 13552079962, xingying@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour volume reduction rate (time frame: 6 month and 12 month post RFA). 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 5 Nov 2026.