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

This study has been completed.
Information provided by (Responsible Party):
feng xiaobin, Southwest Hospital, China Identifier:
First received: November 9, 2011
Last updated: July 1, 2014
Last verified: November 2012
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
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:

Further study details as provided by feng xiaobin, Southwest Hospital, China:

Primary Outcome Measures:
  • 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:
  • 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

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

Estimated Enrollment: 140
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: October 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


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01471080

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

Responsible Party: feng xiaobin, Institute of hepatobiliary surgery,southwest hospital, Southwest Hospital, China Identifier: NCT01471080     History of Changes
Other Study ID Numbers: swhb004
Study First Received: November 9, 2011
Last Updated: July 1, 2014

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
Hematinics processed this record on May 25, 2017