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

NCT01471080 — Not applicable, Completed, 140 participants, Southwest Hospital, China

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

Registry	NCT01471080
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	140 (Estimated)
Sponsor	Southwest Hospital, China (Other)
Conditions	Laparoscopic Hepatectomy, Radio-frequency Ablation, Giant Cavernous Hemangiomas, Liver
Interventions	RFA, hepatectomy (Procedure)
Dates	start 2011-11-01, primary completion 2013-10-01, completion 2014-01-01, first posted 2011-11-11, last updated 2014-07-02
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
RFA group	Experimental	Procedure: RFA	using RFA to treat cavernous hemangiomas
hepatectomy group	Active comparator	Procedure: hepatectomy	using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver

RFA (Procedure), also known as radiofrequence ablation: using RFA to treat cavernous hemangiomas
hepatectomy (Procedure), also known as liver resection: using hepatectomy to treat cavernous hemangiomas

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Institute of hepatobiliary surgery,southwest hospital	Chongqing, Chongqing Municipality	China