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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Total survival time and disease free survival time

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Principal Investigator

Xiujun Cai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sir Run Run Shaw Hospital

Authority:

China: Ministry of Health

Study ID:

SRRSH20121225-2

NCT ID:

NCT01768741

Start Date:

December 2012

Completion Date:

December 2021

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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