Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Ho-Seong Han, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00606385
First received: January 21, 2008
Last updated: December 4, 2013
Last verified: December 2013
  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: 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:


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: 84
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (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

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
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, see Learn About Clinical Studies.

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:
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
Study First Received: January 21, 2008
Last Updated: December 4, 2013
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
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Liver Extracts
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014