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Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma


N/A
20 Years
80 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma


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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence rate

Outcome Time Frame:

2 years after operation

Safety Issue:

Yes

Principal Investigator

Ho-Seong Han, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Surgery, Seoul National University Bundang Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

SNUBH-GS-HBP1

NCT ID:

NCT00606385

Start Date:

December 2007

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • Recurrence
  • Survival
  • Immunology
  • Laparoscopy
  • Carcinoma
  • Carcinoma, Hepatocellular

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