Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

Liver Tumor Clinical Trial

Official title:

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02203409
• Other study ID #: SWHZSG005
• Secondary ID: 30972948
• Status: Recruiting
• Start date: July 2014
• Est. completion date: August 2022

Study information

• Verified date: January 2022
• Source: Southwest Hospital, China
• Contact: Shuguo Zheng
• Phone: 86-13508308676
• Email: shuguozh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a single center. The validity, feasibility and limitations were assessed objectively through our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective and feasible.

Description:

Background: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a breakthrough in the field of hepatobiliary surgery in recent years，which stimulates the remnant liver volume(RLV) grew by 74%-87.2% in 9 to 13 days。The published literature reported that the two stages of ALPPS are the conventional laparotomy surgery，Patients need to undergo the injury of two open operations in a short time. The incidence of postoperative complications and mortality rate is as high as 53% -73% and 12%-27%.The aim of this study was to evaluate the results with laparoscopic ALPPS procedure in a single center, with special emphasis in validity, feasibility and limitations. Results: Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, long-term curative effect and survival time were collected and analysed. Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with marginally resectable or primarily non-resectable locally advanced liver tumors
• Insufficient future liver remnant (FLR) either in volume or quality

Exclusion Criteria:

• Unresectable liver metastases in the future liver remnant or unresectable extrahepatic metastases
• Severe portal hypertension
• High anesthesiological risk
• Unresectable primary tumor

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Intervention

Procedure:
• Laparoscopic ALPPS
Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Shuguo Zheng, MD

Country where clinical trial is conducted

China, 

References & Publications (11)

Alvarez FA, Ardiles V, Sanchez Claria R, Pekolj J, de Santibañes E. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS): tips and tricks. J Gastrointest Surg. 2013 Apr;17(4):814-21. doi: 10.1007/s11605-012-2092-2. Epub 2012 Nov 27. — View Citation

Barbaro B, Caputo F, Tebala C, Di Stasi C, Vellone M, Giuliante F, Nuzzo G, Bonomo L. Preoperative right portal vein embolisation: indications and results. Radiol Med. 2009 Jun;114(4):553-70. doi: 10.1007/s11547-009-0383-9. Epub 2009 Apr 13. English, Italian. — View Citation

de Baere T, Denys A, Madoff DC. Preoperative portal vein embolization: indications and technical considerations. Tech Vasc Interv Radiol. 2007 Mar;10(1):67-78. Review. — View Citation

Dokmak S, Belghiti J. Which limits to the "ALPPS" approach? Ann Surg. 2012 Sep;256(3):e6; author reply e16-7. doi: 10.1097/SLA.0b013e318265fd64. — View Citation

Gruttadauria S, Vasta F, Minervini MI, Piazza T, Arcadipane A, Marcos A, Gridelli B. Significance of the effective remnant liver volume in major hepatectomies. Am Surg. 2005 Mar;71(3):235-40. — View Citation

Li J, Girotti P, Königsrainer I, Ladurner R, Königsrainer A, Nadalin S. ALPPS in right trisectionectomy: a safe procedure to avoid postoperative liver failure? J Gastrointest Surg. 2013 May;17(5):956-61. doi: 10.1007/s11605-012-2132-y. Epub 2013 Jan 4. — View Citation

Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. — View Citation

Sala S, Ardiles V, Ulla M, Alvarez F, Pekolj J, de Santibañes E. Our initial experience with ALPPS technique: encouraging results. Updates Surg. 2012 Sep;64(3):167-72. doi: 10.1007/s13304-012-0175-y. Epub 2012 Aug 18. — View Citation

Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Hörbelt R, Kroemer A, Loss M, Rümmele P, Scherer MN, Padberg W, Königsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5. — View Citation

Toyosaka A, Okamoto E, Mitsunobu M, Oriyama T, Nakao N, Miura K. Intrahepatic metastases in hepatocellular carcinoma: evidence for spread via the portal vein as an efferent vessel. Am J Gastroenterol. 1996 Aug;91(8):1610-5. Retraction in: Am J Gastroenterol. 1998 Mar;93(3):492. — 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. Epub 2012 Oct 26. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the procedure defined as the incidence of postoperative complications and mortality		within the first 90 days after the first stage
Secondary	survival rate	follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates,disease-free survival rates , recurrence and metastasis rate.	3 years