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

First Received on January 21, 2008. Last Updated on July 1, 2011 History of Changes

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00606385

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:

MedlinePlus related topics: High Blood Pressure

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:

Yoon YS, Han HS, Choi YS, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic right posterior sectionectomy for hepatocellular carcinoma. J Laparoendosc Adv Surg Tech A. 2006 Jun;16(3):274-7.

Min SK, Han HS, Kim SW, Park YH, Lee HO, Lee JH. Initial experiences with laparoscopy-assisted and total laparoscopy for anatomical liver resection: a preliminary study. J Korean Med Sci. 2006 Feb;21(1):69-74.

Yoon YS, Han HS, Choi YS, Lee SI, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic left lateral sectionectomy performed in a child with benign liver mass. J Pediatr Surg. 2006 Jan;41(1):e25-8.

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 February 09, 2012