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

This study is currently recruiting participants.

Verified November 2012 by Southwest Hospital, China

Sponsor:

Information provided by (Responsible Party):

feng xiaobin, Southwest Hospital, China

ClinicalTrials.gov Identifier:

NCT01471080

First received: November 9, 2011

Last updated: November 26, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention
Laparoscopic Hepatectomy Radio-frequency Ablation Giant Cavernous Hemangiomas Liver	Procedure: RFA Procedure: hepatectomy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.

Resource links provided by NLM:

Genetics Home Reference related topics: cerebral cavernous malformation

MedlinePlus related topics: Birthmarks

U.S. FDA Resources

Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:

disappearance rate of disease [ Time Frame: 1 month ] [ Designated as safety issue: No ]
to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT

Secondary Outcome Measures:

complication rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	November 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RFA group using RFA to treat cavernous hemangiomas	Procedure: RFA using RFA to treat cavernous hemangiomas Other Name: radiofrequence ablation
Active Comparator: hepatectomy group using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver	Procedure: hepatectomy using hepatectomy to treat cavernous hemangiomas Other Name: liver resection

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471080

Locations

China, Chongqing
Institute of hepatobiliary surgery,southwest hospital	Recruiting
Chongqing, Chongqing, China, 400038
Contact: feng xiaobin, MD +86-23-13228683243 fengxiaobin200708@yahoo.com.cn
Principal Investigator: feng xiaobin, MD

Sponsors and Collaborators

Southwest Hospital, China

More Information

No publications provided

Responsible Party:	feng xiaobin, Institute of hepatobiliary surgery,southwest hospital, Southwest Hospital, China
ClinicalTrials.gov Identifier:	NCT01471080 History of Changes
Other Study ID Numbers:	swhb004
Study First Received:	November 9, 2011
Last Updated:	November 26, 2012
Health Authority:	China: Ethics Committee

Keywords provided by Southwest Hospital, China:

laparoscopic hepatectomy
radio-frequency ablation
giant cavernous hemangiomas
liver

Additional relevant MeSH terms:

Hemangioma
Hemangioma, Cavernous
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms

Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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