Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ho-Seong Han, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00606385
First received: January 21, 2008
Last updated: October 27, 2016
Last verified: October 2016

January 21, 2008
October 27, 2016
December 2007
June 2017   (final data collection date for primary outcome measure)
Recurrence rate [ Time Frame: 2 years after operation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00606385 on ClinicalTrials.gov Archive Site
Survival [ Time Frame: 2 years after operation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma

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

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)
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
Procedure: Liver resection
Laparoscopic or Open hepatectomy
  • Experimental: laparoscopic liver resection
    Patients who underwent laparoscopic liver resection for HCC
    Intervention: Procedure: Liver resection
  • Active Comparator: open liver resection
    Patients who underwent open liver resection for HCC
    Intervention: Procedure: Liver resection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
84
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00606385
SNUBH-GS-HBP1, SNUBH-GS-HBP1
Yes
No
Not Provided
Ho-Seong Han, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Study Chair: Ho-Seong Han, MD, PhD Department of Surgery, Seoul National University Bundang Hospital
Seoul National University Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP