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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: RFA
* Procedure: hepatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA group<br>using RFA to treat cavernous hemangiomas | Procedure: RFA<br>* using RFA to treat cavernous hemangiomas<br>* Other names: radiofrequence ablation;|
| Active Comparator: hepatectomy group<br>using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver | Procedure: hepatectomy<br>* using hepatectomy to treat cavernous hemangiomas<br>* Other names: liver resection;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic hepatectomy, radio-frequency ablation, giant cavernous hemangiomas, liver