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

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ClinicalTrials.gov Identifier: NCT00606385
Recruitment Status : 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

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

  1. 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
  2. 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 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

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



Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 2 years after operation ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 years after operation ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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

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
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Ho-Seong Han, MD, PhD Department of Surgery, Seoul National University Bundang Hospital

Publications:
Responsible Party: Ho-Seong Han, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00606385     History of Changes
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:
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
Liver Extracts
Hematinics