Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sir Run Run Shaw Hospital
Sponsor:
Information provided by (Responsible Party):
Xiujun Cai, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier:
NCT01768741
First received: January 13, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Procedure: Laparoscopic liver resection
Procedure: Open liver resection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sir Run Run Shaw Hospital:

Primary Outcome Measures:
  • Total survival time and disease free survival time [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical margins [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Time to functional recovery [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days ] [ Designated as safety issue: No ]
  • Postoperative hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
  • Morbidity and mortality [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Regulatory T cells and associated cytokines in peripheral blood [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Hospital costs [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 9 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic liver resection group Procedure: Laparoscopic liver resection
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
Other Name: Laparoscopic hepatectomy
Active Comparator: Open liver resection Procedure: Open liver resection
participants will be performed with open hepatectomy using laparotomic instruments
Other Name: Open hepatectomy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768741

Contacts
Contact: Xiujun Cai, MD 0086-0571-86006605 caixiujunzju@yahoo.com.cn

Locations
China, Zhejiang
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xiujun Cai, MD    0086-0571-86006605    caixiujunzju@yahoo.com.cn   
Contact: Renan Jin, MS    0086-0571-86006276    jason198508@126.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
Principal Investigator: Xiujun Cai, MD Sir Run Run Shaw Hospital
  More Information

No publications provided

Responsible Party: Xiujun Cai, Executive Vice-President, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT01768741     History of Changes
Other Study ID Numbers: SRRSH20121225-2
Study First Received: January 13, 2013
Last Updated: January 13, 2013
Health Authority: China: Ministry of Health

Keywords provided by Sir Run Run Shaw Hospital:
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 23, 2014