Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Zhejiang University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Open liver resection; Procedure: Laparoscopic liver resection

Study type: Interventional

Funder types: Other

Identifiers

NCT01768741

SRRSH20121225-2

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Laparoscopic liver resection group

Active Comparator group

Treatment:

Procedure: Laparoscopic liver resection

Open liver resection

Active Comparator group

Treatment:

Procedure: Open liver resection