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

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ClinicalTrials.gov Identifier: NCT01471080
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
feng xiaobin, Southwest Hospital, China

November 9, 2011
November 11, 2011
July 2, 2014
November 2011
October 2013   (Final data collection date for primary outcome measure)
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
disappearance of disease [ Time Frame: 1 month ]
to determine the disappearance of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT
Complete list of historical versions of study NCT01471080 on ClinicalTrials.gov Archive Site
  • 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 ]
  • complication rate [ Time Frame: 1 month ]
    obvious complications including bleeding, bile leakage will be take into account.
  • hospital stay and relating overall cost for treatment [ Time Frame: 1 month ]
Not Provided
Not Provided
 
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver:RFA Versus Laparoscopic Hepatectomy.
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Laparoscopic Hepatectomy
  • Radio-frequency Ablation
  • Giant Cavernous Hemangiomas
  • Liver
  • Procedure: RFA
    using RFA to treat cavernous hemangiomas
    Other Name: radiofrequence ablation
  • Procedure: hepatectomy
    using hepatectomy to treat cavernous hemangiomas
    Other Name: liver resection
  • Experimental: RFA group
    using RFA to treat cavernous hemangiomas
    Intervention: Procedure: RFA
  • Active Comparator: hepatectomy group
    using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver
    Intervention: Procedure: hepatectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
200
January 2014
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01471080
swhb004
No
Not Provided
Not Provided
feng xiaobin, Southwest Hospital, China
Southwest Hospital, China
Not Provided
Not Provided
Southwest Hospital, China
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP