Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
Study Details
Study Description
Brief Summary
The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter < 5cm, located in segment II-VI.
Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.
So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.
This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: laparoscopic hepatectomy The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery |
Procedure: laparoscopic hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy
|
| Experimental: Open hepatectomy The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery |
Procedure: Open hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery
|
Outcome Measures
Primary Outcome Measures
- Overall survival [5 years]
The overall survival of HCC patients after operation
Secondary Outcome Measures
- Disease free survival [5 years]
The disease free survival of HCC patients after operation
- Incidence of postoperative complications [1 month]
Incidence of postoperative complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis was HCC
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The tumor was located in segment: II, III, IVb, V, VI
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The tumor diameter < 5cm
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Without thrombosis in the portal vein, hepatic vein or bile duct
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Without intrahepatic and systemic metastasis
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The Child-pugh score was A-B7
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The ASA（American Society of Anesthesiologists） score was I-III
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The patient age was between 18-75
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Sign the informed consent, and can fully understand the research content
Exclusion Criteria:
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Have surgery contraindications
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Pregnant or lactating women
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The Child-pugh score was B8-C
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The ASA（American Society of Anesthesiologists） score was IV-V
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With other malignant tumor
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With mental illness
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Participated in other clinical trials in the last three months
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Underwent other treatments(chemotherapy or radiotherapy) before operation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huashan hospital | Shanghai | China | 200040 |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Lunxiu Qin, MD, Department of general surgery, Huashan hospital, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
- Afaneh C, Kluger MD. Laparoscopic liver resection: lessons at the end of the second decade. Semin Liver Dis. 2013 Aug;33(3):226-35. doi: 10.1055/s-0033-1351780. Epub 2013 Aug 13. Review. Danish, English.
- Buell JF, Cherqui D, Geller DA, O'Rourke N, Iannitti D, Dagher I, Koffron AJ, Thomas M, Gayet B, Han HS, Wakabayashi G, Belli G, Kaneko H, Ker CG, Scatton O, Laurent A, Abdalla EK, Chaudhury P, Dutson E, Gamblin C, D'Angelica M, Nagorney D, Testa G, Labow D, Manas D, Poon RT, Nelson H, Martin R, Clary B, Pinson WC, Martinie J, Vauthey JN, Goldstein R, Roayaie S, Barlet D, Espat J, Abecassis M, Rees M, Fong Y, McMasters KM, Broelsch C, Busuttil R, Belghiti J, Strasberg S, Chari RS; World Consensus Conference on Laparoscopic Surgery. The international position on laparoscopic liver surgery: The Louisville Statement, 2008. Ann Surg. 2009 Nov;250(5):825-30.
- Chen KH, Jeng KS, Huang SH, Chu SH. Laparoscopic caudate hepatectomy for cancer--an innovative approach to the no-man's land. J Gastrointest Surg. 2013 Mar;17(3):522-6. doi: 10.1007/s11605-012-2115-z. Epub 2013 Jan 8.
- Ishizawa T, Gumbs AA, Kokudo N, Gayet B. Laparoscopic segmentectomy of the liver: from segment I to VIII. Ann Surg. 2012 Dec;256(6):959-64. doi: 10.1097/SLA.0b013e31825ffed3.
- Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.
- Huashan 002