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

NCT ID: NCT01471080

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-01-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA group

using RFA to treat cavernous hemangiomas

Group Type: EXPERIMENTAL

RFA

Intervention Type: PROCEDURE

using RFA to treat cavernous hemangiomas

hepatectomy group

using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver

Group Type: ACTIVE_COMPARATOR

hepatectomy

Intervention Type: PROCEDURE

using hepatectomy to treat cavernous hemangiomas

Interventions

RFA

using RFA to treat cavernous hemangiomas

Intervention Type: PROCEDURE

hepatectomy

using hepatectomy to treat cavernous hemangiomas

Intervention Type: PROCEDURE

Other Intervention Names

radiofrequence ablation; liver resection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

feng xiaobin

Institute of hepatobiliary surgery,southwest hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

swhb004

Identifier Type: -

Identifier Source: org_study_id