NCT00606385

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

9.5 years

First QC Date

January 21, 2008

Last Update Submit

October 27, 2016

Conditions

Keywords

RecurrenceSurvivalImmunologyLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    2 years after operation

Secondary Outcomes (1)

  • Survival

    2 years after operation

Study Arms (2)

laparoscopic liver resection

EXPERIMENTAL

Patients who underwent laparoscopic liver resection for HCC

Procedure: Liver resection

open liver resection

ACTIVE COMPARATOR

Patients who underwent open liver resection for HCC

Procedure: Liver resection

Interventions

Laparoscopic or Open hepatectomy

laparoscopic liver resectionopen liver resection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiologically diagnosed hepatocellular carcinoma
  • Child classification A or B
  • Aged 20 to 80
  • Informed consent taken

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 16796440BACKGROUND
  • 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.

    PMID: 16479068BACKGROUND
  • 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.

    PMID: 16410084BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ho-Seong Han, MD, PhD

    Department of Surgery, Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 4, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations