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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606385
First Posted: February 4, 2008
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ho-Seong Han, Seoul National University Hospital
  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: Liver resection

Study Type: Interventional
Study Design: 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

Further study details as provided by Ho-Seong Han, Seoul National University Hospital:

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

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

Estimated Enrollment: 84
Study Start Date: December 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  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
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
  More Information

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 Submitted: January 21, 2008
First Posted: February 4, 2008
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