Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis

NCT ID: NCT01992978

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-12-31

Brief Summary

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Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted(RFA)hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas(HCC),but its influence on the prognosis of HCC patients,especially for those with cirrhosis,is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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radiofrequency-assisted resection group(RF-R)

Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.

Group Type EXPERIMENTAL

Radiofrequency-assisted Hepatectomy

Intervention Type PROCEDURE

Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.

conventional liver resection group(CLR-R)

Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical.

Group Type ACTIVE_COMPARATOR

Conventional Hepatectomy

Intervention Type PROCEDURE

Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.

Interventions

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Radiofrequency-assisted Hepatectomy

Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.

Intervention Type PROCEDURE

Conventional Hepatectomy

Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Aged from 18 to 65 years , no gender restriction.
* Clinical diagnosis of resectable HCC.
* Preoperative liver function test showed Child-Pugh Class A or B.
* Indocyanine green retention at 15 minutes (ICG-15) of \<30%.
* Acceptable clotting profile :platelet count \> 50 x 109/L and a prolonged prothrombin time of \< 5 seconds.
* Enough relative residual liver volume (%RLV) ≥ 40%.
* No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
* No other anti-tumor therapy received before the treatment.
* No metastasis in lymphnode or other organs.
* Written consent inform assigned.

Exclusion Criteria

* Pregnancy.
* Intraoperative findings of tumor rupture,extrahepatic tumor or lymphnode metastasis.
* Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Li Xiaowu,MD

Dr.Xiaowu Li

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaowu Li, MD-Ph D

Role: STUDY_DIRECTOR

Institute of hepatobiliry surgery,Southwest hospital

Locations

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Institute of Hepatobiliry surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rui Guo, Master of Medicine

Role: CONTACT

86-23-15922654727

Li Liu, MD

Role: CONTACT

86-23-68754374

Facility Contacts

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Rui Guo, Master of Medicine

Role: primary

86-23-15922654727

Other Identifiers

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SWHB2013-005

Identifier Type: -

Identifier Source: org_study_id