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Not yet recruitingNCT07919860Updated Nov 5, 2026

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 in Hepatic Hemangioma, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Beijing Tiantan Hospital · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Hepatic Hemangioma

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03

In context

Hemangioma

68 studies on the registry are indexed under Hemangioma; 11 are open to participants now.

This study's planned enrollment of 80 is above the median of 71 across 24 observational studies indexed under Hemangioma.

Browse Hemangioma studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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 criteria

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 ; 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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Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Short-interval group

    RFA is performed at 10-14 days after TAE

    Procedure: transcatheter arterial embolization (TAE) · Procedure: radiofrequency ablation (RFA)

  • Long-interval group

    RFA is performed at 2-3 months after TAE

    Procedure: transcatheter arterial embolization (TAE) · Procedure: radiofrequency ablation (RFA)

Interventions

  • Proceduretranscatheter arterial embolization (TAE)

    Right femoral artery access; embolic agents: gelatin sponge particles combined with lipiodol; procedural endpoint: cessation of lipiodol inflow into hemangioma lesion

  • Procedureradiofrequency 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

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What researchers measure

Primary outcomes

  1. Tumour volume reduction rate

    Time frame: 6 month and 12 month post RFA

Secondary outcomes

  1. Peri-procedural complication incidence

    Time frame: day 1 post TAE and day 1 / day 4 post RFA

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 5, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2029
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07919860
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Nov 5, 2026

Study contacts

Ying Xing
Contact
xingying@bjtth.org
+86 13552079962

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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