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

A

Army Medical University

Status

Completed

Conditions

Laparoscopic Hepatectomy
Giant Cavernous Hemangiomas
Radio-frequency Ablation
Liver

Treatments

Procedure: RFA
Procedure: hepatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01471080
swhb004

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

RFA group
Experimental group
Description:
using RFA to treat cavernous hemangiomas
Treatment:
Procedure: RFA
hepatectomy group
Active Comparator group
Description:
using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver
Treatment:
Procedure: hepatectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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