Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
NCT ID: NCT02526043
Last Updated: 2022-08-18
Study Results
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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UNKNOWN
NA
180 participants
INTERVENTIONAL
2015-08-31
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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laparoscopic hepatectomy
The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery
laparoscopic hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy
Open hepatectomy
The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery
Open hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery
Interventions
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laparoscopic hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy
Open hepatectomy
The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery
Eligibility Criteria
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Inclusion Criteria
2. The tumor was located in segment: II, III, IVb, V, VI
3. The tumor diameter \< 5cm
4. Without thrombosis in the portal vein, hepatic vein or bile duct
5. Without intrahepatic and systemic metastasis
6. The Child-pugh score was A-B7
7. The ASA（American Society of Anesthesiologists） score was I-III
8. The patient age was between 18-75
9. Sign the informed consent, and can fully understand the research content
Exclusion Criteria
2. Pregnant or lactating women
3. The Child-pugh score was B8-C
4. The ASA（American Society of Anesthesiologists） score was IV-V
5. With other malignant tumor
6. With mental illness
7. Participated in other clinical trials in the last three months
8. Underwent other treatments(chemotherapy or radiotherapy) before operation
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Lunxiu Qin
Department of general surgery, Huashan hospital
Principal Investigators
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Lunxiu Qin, MD
Role: PRINCIPAL_INVESTIGATOR
Department of general surgery, Huashan hospital, Fudan University
Locations
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Huashan hospital
Shanghai, , China
Countries
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References
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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.
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.
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. doi: 10.1097/sla.0b013e3181b3b2d8.
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. Danish, English.
Bryant R, Laurent A, Tayar C, Cherqui D. Laparoscopic liver resection-understanding its role in current practice: the Henri Mondor Hospital experience. Ann Surg. 2009 Jul;250(1):103-11. doi: 10.1097/SLA.0b013e3181ad6660.
Topal B, Fieuws S, Aerts R, Vandeweyer H, Penninckx F. Laparoscopic versus open liver resection of hepatic neoplasms: comparative analysis of short-term results. Surg Endosc. 2008 Oct;22(10):2208-13. doi: 10.1007/s00464-008-0023-9. Epub 2008 Jul 12.
Tranchart H, Di Giuro G, Lainas P, Roudie J, Agostini H, Franco D, Dagher I. Laparoscopic resection for hepatocellular carcinoma: a matched-pair comparative study. Surg Endosc. 2010 May;24(5):1170-6. doi: 10.1007/s00464-009-0745-3. Epub 2009 Nov 14.
Cai XJ, Yang J, Yu H, Liang X, Wang YF, Zhu ZY, Peng SY. Clinical study of laparoscopic versus open hepatectomy for malignant liver tumors. Surg Endosc. 2008 Nov;22(11):2350-6. doi: 10.1007/s00464-008-9789-z. Epub 2008 Feb 23.
Dagher I, Lainas P, Carloni A, Caillard C, Champault A, Smadja C, Franco D. Laparoscopic liver resection for hepatocellular carcinoma. Surg Endosc. 2008 Feb;22(2):372-8. doi: 10.1007/s00464-007-9487-2. Epub 2007 Aug 18.
Lee KF, Chong CN, Wong J, Cheung YS, Wong J, Lai P. Long-term results of laparoscopic hepatectomy versus open hepatectomy for hepatocellular carcinoma: a case-matched analysis. World J Surg. 2011 Oct;35(10):2268-74. doi: 10.1007/s00268-011-1212-6.
Slim A, Garancini M, Di Sandro S, Mangoni I, Lauterio A, Giacomoni A, De Carlis L. Laparoscopic versus open liver surgery: a single center analysis of post-operative in-hospital and post-discharge results. Langenbecks Arch Surg. 2012 Dec;397(8):1305-11. doi: 10.1007/s00423-012-0992-y. Epub 2012 Aug 24.
Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26.
Other Identifiers
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Huashan 002
Identifier Type: -
Identifier Source: org_study_id
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