Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

This study is currently recruiting participants.

Verified by Seoul National University Hospital, January 2008

Sponsored by:	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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma

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 Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Laparoscopic liver resection	Procedure: Hepatectomy Laparoscopic or Open hepatectomy
2 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, Gyeonggi-do
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:	Department of Surgery, Seoul National University College of Medicine ( Ho-Seong Han / Assocoate Professor )
Study ID Numbers:	SNUBH-GS-HBP1, SNUBH-GS-HBP1
Study First Received:	January 21, 2008
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00606385
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Recurrence
Survival
Immunology
Laparoscopy

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Recurrence
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009