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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
feng xiaobin, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01471080
First received: November 9, 2011
Last updated: July 1, 2014
Last verified: November 2012
  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:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Chongqing
Institute of hepatobiliary surgery,southwest hospital
Chongqing, Chongqing, China, 400038
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: July 1, 2014
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
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014