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

Primary Purpose

Hepatocellular Carcinoma, Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiofrequency-assisted Hepatectomy
Conventional Hepatectomy
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring radiofrequency-assisted（RF）, hepatectomy, postoperative liver injury

Eligibility Criteria

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

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.

Sites / Locations

  • Institute of Hepatobiliry surgery,Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

radiofrequency-assisted resection group（RF-R)

conventional liver resection group（CLR-R）

Arm Description

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

Outcomes

Primary Outcome Measures

Postoperative liver injury
The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.

Secondary Outcome Measures

Number of Participants with Adverse Events
It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured.
Overall survival

Full Information

First Posted
November 11, 2013
Last Updated
November 22, 2015
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01992978
Brief Title
Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis
Official Title
The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Cirrhosis
Keywords
radiofrequency-assisted（RF）, hepatectomy, postoperative liver injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radiofrequency-assisted resection group（RF-R)
Arm Type
Experimental
Arm Description
Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.
Arm Title
conventional liver resection group（CLR-R）
Arm Type
Active Comparator
Arm Description
Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency-assisted Hepatectomy
Intervention Description
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
Intervention Name(s)
Conventional Hepatectomy
Intervention Description
Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.
Primary Outcome Measure Information:
Title
Postoperative liver injury
Description
The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.
Time Frame
postoperative 90 days
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured.
Time Frame
postoperative 90 days
Title
Overall survival
Time Frame
1,3,5-year overall survival
Other Pre-specified Outcome Measures:
Title
Blood parameter change after operation
Description
Blood parameter change after operation is measured by postoperative blood routine test till the hospitalization. The estimated average postoperative hospitalization ranges from 10 ot 15 days (generally 2 weeks). If the incidence of postoperative hepatic insufficiency occurred beyond hospitalization,blood routine test is also necessarily counted in.
Time Frame
discharge from hospital (2 weeks)

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Guo, Master of Medicine
Phone
86-23-15922654727
Email
ruixx032@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Liu, MD
Phone
86-23-68754374
Email
guor2006@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowu Li, MD-Ph D
Organizational Affiliation
Institute of hepatobiliry surgery,Southwest hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Hepatobiliry surgery,Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Guo, Master of Medicine
Phone
86-23-15922654727
Email
ruixx032@163.com
First Name & Middle Initial & Last Name & Degree
Xiaowu Li, MD-Ph D

12. IPD Sharing Statement

Learn more about this trial

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

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