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NCT Number: NCT01471080

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

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.

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Key information

Conditions

Laparoscopic Hepatectomy Giant Cavernous Hemangiomas Liver Radio-frequency Ablation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, 400038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RFA

Procedure

using RFA to treat cavernous hemangiomas

Other names: radiofrequence ablation

Hepatectomy

Procedure

using hepatectomy to treat cavernous hemangiomas

Other names: liver resection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Registry information

Official study title

A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 11, 2011
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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