search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Liver resection
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Recurrence, Survival, Immunology, Laparoscopy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

laparoscopic liver resection

open liver resection

Arm Description

Patients who underwent laparoscopic liver resection for HCC

Patients who underwent open liver resection for HCC

Outcomes

Primary Outcome Measures

Recurrence rate

Secondary Outcome Measures

Survival

Full Information

First Posted
January 21, 2008
Last Updated
October 27, 2016
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00606385
Brief Title
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC
Acronym
HCC
Official Title
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Recurrence, Survival, Immunology, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic liver resection
Arm Type
Experimental
Arm Description
Patients who underwent laparoscopic liver resection for HCC
Arm Title
open liver resection
Arm Type
Active Comparator
Arm Description
Patients who underwent open liver resection for HCC
Intervention Type
Procedure
Intervention Name(s)
Liver resection
Intervention Description
Laparoscopic or Open hepatectomy
Primary Outcome Measure Information:
Title
Recurrence rate
Time Frame
2 years after operation
Secondary Outcome Measure Information:
Title
Survival
Time Frame
2 years after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Seong Han, MD, PhD
Organizational Affiliation
Department of Surgery, Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16796440
Citation
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. doi: 10.1089/lap.2006.16.274.
Results Reference
background
PubMed Identifier
16479068
Citation
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. doi: 10.3346/jkms.2006.21.1.69.
Results Reference
background
PubMed Identifier
16410084
Citation
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. doi: 10.1016/j.jpedsurg.2005.10.068.
Results Reference
background

Learn more about this trial

Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

We'll reach out to this number within 24 hrs