Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Sir Run Run Shaw Hospital500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

500

Conditions

Hepatocellular Carcinoma

Interventions

Laparoscopic liver resectionPROCEDURE

participants will be performed with laparoscopic hepatectomy using laparoscopic instruments

Open liver resectionPROCEDURE

participants will be performed with open hepatectomy using laparotomic instruments

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma * Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ * 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

Locations (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Total survival time and disease free survival time

Time frame: up to 5 years

Secondary Outcomes

Surgical margins

Time frame: 7 days

Time to functional recovery

Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days

Postoperative hospital stay

Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days

Morbidity and mortality

Time frame: up to 3 months

Quality of life

Time frame: up to 1 year

Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor

Time frame: participants will be followed for the duration of operation, an expected average of 90 min

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

Time frame: up to 5 years

Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue

Time frame: 7 days

Central Contacts

Xiujun Cai, MD

CONTACT

0086-0571-86006605 caixiujunzju@yahoo.com.cn

Data from ClinicalTrials.gov

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