Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02526043
• Other study ID #: Huashan 002
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Huashan hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. Epub 2007 Aug 18. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. d — View 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. — View 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. — View Citation

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. Ep — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The overall survival of HCC patients after operation	5 years
Secondary	Disease free survival	The disease free survival of HCC patients after operation	5 years
Secondary	Incidence of postoperative complications	Incidence of postoperative complications	1 month