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

Primary Purpose

Laparoscopic Hepatectomy, Radio-frequency Ablation, Giant Cavernous Hemangiomas

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RFA
hepatectomy
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Hepatectomy focused on measuring laparoscopic hepatectomy, radio-frequency ablation, giant cavernous hemangiomas, liver

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of hepatobiliary surgery,southwest hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RFA group

hepatectomy group

Arm Description

using RFA to treat cavernous hemangiomas

using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver

Outcomes

Primary Outcome Measures

disappearance rate of disease
to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT

Secondary Outcome Measures

complication rate
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

Full Information

First Posted
November 9, 2011
Last Updated
July 1, 2014
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01471080
Brief Title
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver
Official Title
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver：RFA Versus Laparoscopic Hepatectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Hepatectomy, Radio-frequency Ablation, Giant Cavernous Hemangiomas, Liver
Keywords
laparoscopic hepatectomy, radio-frequency ablation, giant cavernous hemangiomas, liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA group
Arm Type
Experimental
Arm Description
using RFA to treat cavernous hemangiomas
Arm Title
hepatectomy group
Arm Type
Active Comparator
Arm Description
using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver
Intervention Type
Procedure
Intervention Name(s)
RFA
Other Intervention Name(s)
radiofrequence ablation
Intervention Description
using RFA to treat cavernous hemangiomas
Intervention Type
Procedure
Intervention Name(s)
hepatectomy
Other Intervention Name(s)
liver resection
Intervention Description
using hepatectomy to treat cavernous hemangiomas
Primary Outcome Measure Information:
Title
disappearance rate of disease
Description
to determine the disappearance rate of disease by imaging modality using enhanced Ultrasound examine and/or enhanced CT
Time Frame
1 month
Secondary Outcome Measure Information:
Title
complication rate
Description
obvious complications including bleeding, bile leakage will be take into account.recover rate. symptom relief and satisfactory of the treatment
Time Frame
1 month
Title
hospital stay and relating overall cost for treatment
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Institute of hepatobiliary surgery,southwest hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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