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

NCT01471080 | Completed

• 1 other identifier: swhb004
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Hepatectomy; Radio-frequency Ablation; Giant Cavernous Hemangiomas; Liver

Keywords

laparoscopic hepatectomy; radio-frequency ablation; giant cavernous hemangiomas; liver

Outcome Measures

Primary Outcomes (1)

• disappearance rate of disease

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

  1 month

Secondary Outcomes (2)

• complication rate

  1 month

• hospital stay and relating overall cost for treatment

  1 month

Study Arms (2)

RFA group

EXPERIMENTAL

using RFA to treat cavernous hemangiomas

Procedure: RFA

hepatectomy group

ACTIVE COMPARATOR

using laparoscopic hepatectomy to treat cavernous hemangiomas of the liver

Procedure: hepatectomy

Interventions

RFA PROCEDURE

using RFA to treat cavernous hemangiomas

Also known as: radiofrequence ablation

RFA group

hepatectomy PROCEDURE

using hepatectomy to treat cavernous hemangiomas

Also known as: liver resection

hepatectomy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute of hepatobiliary surgery,southwest hospital

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 2, 2014

Record last verified: 2012-11

Locations

CN (1)