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Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

This study is currently recruiting participants.
Verified July 2011 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00606385
First received: January 21, 2008
Last updated: July 1, 2011
Last verified: July 2011
History of Changes
  Purpose

Short-term outcomes of laparoscopic liver resection is better than those of open liver resection

Laparoscopic liver resection is better than open resection in immunological aspects


Condition Intervention
Hepatocellular Carcinoma
 Procedure: Hepatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Recurrence rate [ Time Frame: 2 years after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 2 years after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 198
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Laparoscopic liver resection group

Laparoscopic liver resection group

  • Patients who underwent laparoscopic liver resection
 Procedure: Hepatectomy
Laparoscopic or Open hepatectomy
2. Open liver resection group

Open liver resection group

  • patients who underwent open liver resection
 Procedure: Hepatectomy
Laparoscopic or Open hepatectomy

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radiologically diagnosed hepatocellular carcinoma
  • Child classification A or B
  • Aged 20 to 80
  • Informed consent taken

Exclusion Criteria:

  • Child classification C
  • Extrahepatic metastasis
  • Tumor located in central area or adjacent to middle hepatic vein
  • Recurred hepatocellular carcinoma
  • Critically ill patient
  • Patient with psychiatric disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606385

Contacts
Contact: Ho-Seong Han, MD, PhD 82-31-787-7091 hanhs@snubh.org

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Ho-Seong Han, MD, PhD     82-31-787-7091     hanhs@snubh.org    
Principal Investigator: Ho-Seong Han, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Ho-Seong Han, MD, PhD Department of Surgery, Seoul National University Bundang Hospital
  More Information

Publications:

Responsible Party: Ho-Seong Han / Assocoate Professor, Department of Surgery, Seoul National University College of Medicine
ClinicalTrials.gov Identifier: NCT00606385     History of Changes
Other Study ID Numbers: SNUBH-GS-HBP1, SNUBH-GS-HBP1
Study First Received: January 21, 2008
Last Updated: July 1, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Recurrence
Survival
Immunology
Laparoscopy

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 May 19, 2013