A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver

A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471080

Enrollment

140

Registered

2011-11-11

Start date

2011-11-30

Completion date

2014-01-31

Last updated

2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cavernous Hemangiomas, Laparoscopic Hepatectomy, Liver, Radio-frequency Ablation

Keywords

laparoscopic hepatectomy, radio-frequency ablation, giant cavernous hemangiomas, liver

Brief 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. 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.

Interventions

PROCEDURERFA

using RFA to treat cavernous hemangiomas

PROCEDUREhepatectomy

using hepatectomy to treat cavernous hemangiomas

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
disappearance rate of disease	1 month	to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT

Secondary

Measure	Time frame	Description
complication rate	1 month	obvious complications including bleeding, bile leakage will be take into account.recover rate. symptom relief and satisfactory of the treatment
hospital stay and relating overall cost for treatment	1 month	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026