Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

NCT02526043 | Unknown

• 1 other identifier: Huashan 002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The overall survival of HCC patients after operation

  5 years

Secondary Outcomes (2)

• Disease free survival

  5 years

• Incidence of postoperative complications

  1 month

Study Arms (2)

laparoscopic hepatectomy

EXPERIMENTAL

The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery

Procedure: laparoscopic hepatectomy

Open hepatectomy

EXPERIMENTAL

The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery

Procedure: Open hepatectomy

Interventions

laparoscopic hepatectomy PROCEDURE

The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy

laparoscopic hepatectomy

Open hepatectomy PROCEDURE

The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery

Open hepatectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis was HCC
• The tumor was located in segment: II, III, IVb, V, VI
• The tumor diameter \< 5cm
• Without thrombosis in the portal vein, hepatic vein or bile duct
• Without intrahepatic and systemic metastasis
• The Child-pugh score was A-B7
• The ASA（American Society of Anesthesiologists） score was I-III
• The patient age was between 18-75
• Sign the informed consent, and can fully understand the research content

You may not qualify if:

• Have surgery contraindications
• Pregnant or lactating women
• The Child-pugh score was B8-C
• The ASA（American Society of Anesthesiologists） score was IV-V
• With other malignant tumor
• With mental illness
• Participated in other clinical trials in the last three months
• Underwent other treatments(chemotherapy or radiotherapy) before operation

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huashan hospital

Shanghai, 200040, China

Location

Related Publications (13)

• 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.

  PMID: 22968066 BACKGROUND

• Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.

  PMID: 1833688 BACKGROUND

• 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.

  PMID: 23297026 BACKGROUND

• 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.

  PMID: 19916210 BACKGROUND

• 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.

  PMID: 23943103 BACKGROUND

• 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.

  PMID: 19561476 RESULT

• 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.

  PMID: 18622562 RESULT

• 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.

  PMID: 19915908 RESULT

• 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.

  PMID: 18297354 RESULT

• 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.

  PMID: 17704878 RESULT

• 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.

  PMID: 21842300 RESULT

• 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.

  PMID: 22918605 RESULT

• 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.

  PMID: 23099728 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lunxiu Qin, MD

  Department of general surgery, Huashan hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of general surgery, Huashan hospital

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 18, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)