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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471080
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : July 2, 2014
Information provided by (Responsible Party):
feng xiaobin, 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Hepatectomy Radio-frequency Ablation Giant Cavernous Hemangiomas Liver Procedure: RFA Procedure: hepatectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver:RFA Versus Laparoscopic Hepatectomy.
Study Start Date : November 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

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MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. disappearance rate of disease [ Time Frame: 1 month ]
    to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT

Secondary Outcome Measures :
  1. complication rate [ Time Frame: 1 month ]
    obvious complications including bleeding, bile leakage will be take into account.recover rate. symptom relief and satisfactory of the treatment

  2. hospital stay and relating overall cost for treatment [ Time Frame: 1 month ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471080

China, Chongqing
Institute of hepatobiliary surgery,southwest hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Southwest Hospital, China

Responsible Party: feng xiaobin, Institute of hepatobiliary surgery,southwest hospital, Southwest Hospital, China Identifier: NCT01471080     History of Changes
Other Study ID Numbers: swhb004
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: November 2012

Keywords provided by feng xiaobin, Southwest Hospital, China:
laparoscopic hepatectomy
radio-frequency ablation
giant cavernous hemangiomas

Additional relevant MeSH terms:
Hemangioma, Cavernous
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Liver Extracts