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

Not Applicable

Completed

• Conditions: Giant Cavernous Hemangiomas; Radio-frequency Ablation; Laparoscopic Hepatectomy; Liver
• Interventions: Procedure: RFA; Procedure: hepatectomy

• Registration Number: NCT01471080
• Lead Sponsor: Southwest Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Status Verified: 2012-11
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA group	RFA	using RFA to treat cavernous hemangiomas
hepatectomy group	hepatectomy	using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,southwest hospital; 🇨🇳 Chongqing, Chongqing, China