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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992978
• Other study ID #: SWHB2013-005
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2013
• Last updated: November 22, 2015
• Start date: November 2013
• Est. completion date: December 2018

Study information

• Verified date: November 2015
• Source: Southwest Hospital, China
• Contact: Rui Guo, Master of Medicine
• Phone: 86-23-15922654727
• Email: ruixx032[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
China	Institute of Hepatobiliry surgery,Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood parameter change after operation	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.	discharge from hospital (2 weeks)	Yes
Primary	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.	postoperative 90 days	Yes
Secondary	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.	postoperative 90 days	Yes
Secondary	Overall survival		1,3,5-year overall survival	No