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

Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471080
• Other study ID #: swhb004
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: July 1, 2014
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: November 2012
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Giant Cavernous Hemangiomas
• Hemangioma
• Laparoscopic Hepatectomy
• Liver
• Radio-frequency Ablation

Intervention

Procedure:
• RFA
using RFA to treat cavernous hemangiomas
• hepatectomy
using hepatectomy to treat cavernous hemangiomas

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,southwest hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disappearance rate of disease	to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT	1 month	No
Secondary	complication rate	obvious complications including bleeding, bile leakage will be take into account.recover rate. symptom relief and satisfactory of the treatment	1 month	Yes
Secondary	hospital stay and relating overall cost for treatment		1 month	No