Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC

Hepatocellular Carcinoma Clinical Trial

— HCC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00606385
• Other study ID #: SNUBH-GS-HBP1
• Secondary ID: SNUBH-GS-HBP1
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 21, 2008
• Last updated: October 27, 2016
• Start date: December 2007
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 84
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Liver resection
Laparoscopic or Open hepatectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate		2 years after operation	Yes
Secondary	Survival		2 years after operation	Yes