Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01768741
• Other study ID #: SRRSH20121225-2
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2013
• Last updated: November 16, 2015
• Start date: December 2012
• Est. completion date: December 2021

Study information

• Verified date: November 2015
• Source: Sir Run Run Shaw Hospital
• Contact: Xiujun Cai, MD
• Phone: 0086-0571-86006605
• Email: caixiujunzju[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma

• Located at segment ?????b?? or ?

• The tumor location and size do not affect the dissection of hepatic hilar region

• Tumor size less than 10cm

• Without portal vein tumor thrombus

• Without intrahepatic or distant metastasis

• Willingness to participate in the study

• Able to understand the nature of the study and what will be required of them

• Body mass index of between 18 and 35

• Child-Pugh classification of A to B

• American Society of Anesthesiologists (ASA) grading of I to III

Exclusion Criteria:

• Pregnant or lactating women

• Unwillingness to participate

• Inability to give written informed consent

• Child-Pugh classification of C

• ASA grading of IV to V

• Tumor invasion of the inferior vena cava or confluence part of hepatic vein

• Decompensated liver cirrhosis

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Laparoscopic liver resection
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
• Open liver resection
participants will be performed with open hepatectomy using laparotomic instruments

Locations

Country	Name	City	State
China	Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital costs		participants will be followed for the duration of hospital stay, an expected average of 9 days	No
Primary	Total survival time and disease free survival time		up to 5 years	No
Secondary	Surgical margins		7 days	Yes
Secondary	Time to functional recovery		participants will be followed for the duration of hospital stay, an expected average of 6 days	No
Secondary	Postoperative hospital stay		participants will be followed for the duration of hospital stay, an expected average of 7 days	No
Secondary	Morbidity and mortality		up to 3 months	Yes
Secondary	Quality of life		up to 1 year	No
Secondary	Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor		participants will be followed for the duration of operation, an expected average of 90 min	Yes
Secondary	Regulatory T cells and associated cytokines in peripheral blood	Regulatory T cells and associated cytokines in peripheral blood will be tested 1day before operation,5 days, 3,6 months and 1,3,5 years after operation	up to 5 years	No
Secondary	Regulatory T cells and associated cytokines in liver cancer?para-carcinoma and healthy liver tissue		7 days	No