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Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic hepatectomy
Open hepatectomy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis was HCC
  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:

  1. Have surgery contraindications
  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

Sites / Locations

  • Huashan hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

laparoscopic hepatectomy

Open hepatectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival
The overall survival of HCC patients after operation

Secondary Outcome Measures

Disease free survival
The disease free survival of HCC patients after operation
Incidence of postoperative complications
Incidence of postoperative complications

Full Information

First Posted
August 5, 2015
Last Updated
August 16, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02526043
Brief Title
Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
Official Title
A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic hepatectomy
Arm Type
Experimental
Arm Description
The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery
Arm Title
Open hepatectomy
Arm Type
Experimental
Arm Description
The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery
Intervention Type
Procedure
Intervention Name(s)
laparoscopic hepatectomy
Intervention Description
The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy
Intervention Type
Procedure
Intervention Name(s)
Open hepatectomy
Intervention Description
The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery
Primary Outcome Measure Information:
Title
Overall survival
Description
The overall survival of HCC patients after operation
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease free survival
Description
The disease free survival of HCC patients after operation
Time Frame
5 years
Title
Incidence of postoperative complications
Description
Incidence of postoperative complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lunxiu Qin, MD
Organizational Affiliation
Department of general surgery, Huashan hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22968066
Citation
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Results Reference
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PubMed Identifier
1833688
Citation
Reich H, McGlynn F, DeCaprio J, Budin R. Laparoscopic excision of benign liver lesions. Obstet Gynecol. 1991 Nov;78(5 Pt 2):956-8.
Results Reference
background
PubMed Identifier
23297026
Citation
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.
Results Reference
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PubMed Identifier
19916210
Citation
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.
Results Reference
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PubMed Identifier
23943103
Citation
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.
Results Reference
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PubMed Identifier
19561476
Citation
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.
Results Reference
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PubMed Identifier
18622562
Citation
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.
Results Reference
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PubMed Identifier
19915908
Citation
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.
Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

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