Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Open liver resection; Procedure: Laparoscopic liver resection

• Registration Number: NCT01768741
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-13
• Study First Submitted QC: 2013-01-13
• Study First Posted: 2013-01-15
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open liver resection	Open liver resection	-
Laparoscopic liver resection group	Laparoscopic liver resection	-

Primary Outcome Measures

Name	Time	Method
Total survival time and disease free survival time	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital stay	participants will be followed for the duration of hospital stay, an expected average of 7 days
Morbidity and mortality	up to 3 months
Time to functional recovery	participants will be followed for the duration of hospital stay, an expected average of 6 days
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
Regulatory T cells and associated cytokines in peripheral blood	up to 5 years	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
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue	7 days
Surgical margins	7 days
Quality of life	up to 1 year

Trial Locations

Locations (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China