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Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

NCT ID: NCT00606385

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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)

Conditions

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Hepatocellular Carcinoma

Keywords

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Recurrence Survival Immunology Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic liver resection

Patients who underwent laparoscopic liver resection for HCC

Group Type EXPERIMENTAL

Liver resection

Intervention Type PROCEDURE

Laparoscopic or Open hepatectomy

open liver resection

Patients who underwent open liver resection for HCC

Group Type ACTIVE_COMPARATOR

Liver resection

Intervention Type PROCEDURE

Laparoscopic or Open hepatectomy

Interventions

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Liver resection

Laparoscopic or Open hepatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ho-Seong Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ho-Seong Han, MD, PhD

Role: STUDY_CHAIR

Department of Surgery, Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 16796440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16479068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16410084 (View on PubMed)

Other Identifiers

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SNUBH-GS-HBP1

Identifier Type: OTHER

Identifier Source: secondary_id

SNUBH-GS-HBP1

Identifier Type: -

Identifier Source: org_study_id