Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992978
Recruitment Status : Unknown
Verified November 2015 by Li Xiaowu,MD, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Li Xiaowu,MD, Southwest Hospital, China

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Cirrhosis Procedure: Radiofrequency-assisted Hepatectomy Procedure: Conventional Hepatectomy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

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




Primary Outcome Measures :
  1. Postoperative liver injury [ Time Frame: postoperative 90 days ]
    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 :
  1. Number of Participants with Adverse Events [ Time Frame: postoperative 90 days ]
    It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured.

  2. Overall survival [ Time Frame: 1,3,5-year overall survival ]

Other Outcome Measures:
  1. Blood parameter change after operation [ Time Frame: discharge from hospital (2 weeks) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992978


Contacts
Layout table for location contacts
Contact: Rui Guo, Master of Medicine 86-23-15922654727 ruixx032@163.com
Contact: Li Liu, MD 86-23-68754374 guor2006@gmail.com

Locations
Layout table for location information
China, Chongqing
Institute of Hepatobiliry surgery,Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Rui Guo, Master of Medicine    86-23-15922654727    ruixx032@163.com   
Principal Investigator: Xiaowu Li, MD-Ph D         
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Layout table for investigator information
Study Director: Xiaowu Li, MD-Ph D Institute of hepatobiliry surgery,Southwest hospital
Layout table for additonal information
Responsible Party: Li Xiaowu,MD, Dr.Xiaowu Li, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01992978    
Other Study ID Numbers: SWHB2013-005
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by Li Xiaowu,MD, Southwest Hospital, China:
radiofrequency-assisted(RF)
hepatectomy
postoperative liver injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Liver Cirrhosis
Fibrosis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes