Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC (HCC)

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ClinicalTrials.gov Identifier: NCT00606385

Recruitment Status : Unknown

Verified October 2016 by Ho-Seong Han, Seoul National University Hospital.
Recruitment status was: Enrolling by invitation

First Posted : February 4, 2008

Last Update Posted : October 28, 2016

Sponsor:

Information provided by (Responsible Party):

Ho-Seong Han, Seoul National University Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Procedure: Liver resection	Not Applicable

Detailed Description:

Advantages and disadvantages of the laparoscopic compared with the open approach for liver resections

Advantages 1) Less postoperative ascites production 2) Reduced postoperative pain 3) Feasible in selected cirrhotics who have contraindications to open surgery 4) Less intra-abdominal adhesions (easier salvage transplantation) 5) Shorter recovery time 6) Shorter length of stay 7) Reduced financial cost
Disadvantages 1) No manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) High demand in surgical skill (especially major resections)

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	84 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma
Study Start Date :	December 2007
Estimated Primary Completion Date :	June 2017
Estimated Study Completion Date :	June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: laparoscopic liver resection Patients who underwent laparoscopic liver resection for HCC	Procedure: Liver resection Laparoscopic or Open hepatectomy
Active Comparator: open liver resection Patients who underwent open liver resection for HCC	Procedure: Liver resection Laparoscopic or Open hepatectomy

Outcome Measures

Primary Outcome Measures :

Recurrence rate [ Time Frame: 2 years after operation ]

Secondary Outcome Measures :

Survival [ Time Frame: 2 years after operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606385

Locations

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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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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.

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Responsible Party:	Ho-Seong Han, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00606385
Other Study ID Numbers:	SNUBH-GS-HBP1 SNUBH-GS-HBP1 ( Other Identifier: Ministry Of Food And Drug Safety )
First Posted:	February 4, 2008 Key Record Dates
Last Update Posted:	October 28, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Ho-Seong Han, Seoul National University Hospital:


Recurrence Survival Immunology Laparoscopy

Additional relevant MeSH terms:

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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

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