Clinical trial NCT01768741: Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
Official title: A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total survival time and disease free survival time
timeFrame: up to 5 years
Secondary outcomes:
measure: Surgical margins
timeFrame: 7 days
measure: Time to functional recovery
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Postoperative hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Morbidity and mortality
timeFrame: up to 3 months
measure: Quality of life
timeFrame: up to 1 year
measure: Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor
timeFrame: participants will be followed for the duration of operation, an expected average of 90 min
measure: Regulatory T cells and associated cytokines in peripheral blood
timeFrame: up to 5 years
measure: Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue
timeFrame: 7 days
Other outcomes:
measure: Hospital costs
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 9 days
Locations:
city: Hangzhou
country: China
facility: Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Xiujun Cai, MD
role: PRINCIPAL_INVESTIGATOR
References: