Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

NCT ID: NCT02203409

Last Updated: 2022-01-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic ALPPS group

Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach

Laparoscopic ALPPS

Intervention Type PROCEDURE

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy

Interventions

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Laparoscopic ALPPS

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shuguo Zheng, MD

OTHER

Sponsor Role lead

Responsible Party

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Shuguo Zheng, MD

Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shuguo Zheng

Role: STUDY_DIRECTOR

Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Locations

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Southwest Hospital

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuguo Zheng

Role: CONTACT

86-13508308676

Facility Contacts

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Shuguo Zheng, Professor

Role: primary

86-13508308676

References

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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.

Reference Type BACKGROUND
PMID: 15869140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19367466 (View on PubMed)

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. doi: 10.1053/j.tvir.2007.08.003.

Reference Type BACKGROUND
PMID: 17980321 (View on PubMed)

Alvarez FA, Ardiles V, Sanchez Claria R, Pekolj J, de Santibanes 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.

Reference Type BACKGROUND
PMID: 23188224 (View on PubMed)

Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer 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.

Reference Type BACKGROUND
PMID: 22330038 (View on PubMed)

Sala S, Ardiles V, Ulla M, Alvarez F, Pekolj J, de Santibanes 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.

Reference Type BACKGROUND
PMID: 22903531 (View on PubMed)

Li J, Girotti P, Konigsrainer I, Ladurner R, Konigsrainer 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.

Reference Type BACKGROUND
PMID: 23288719 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 22895355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8759671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23099728 (View on PubMed)

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. doi: 10.1097/00000658-200107000-00010.

Reference Type BACKGROUND
PMID: 11420484 (View on PubMed)

Other Identifiers

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30972948

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SWHZSG005

Identifier Type: -

Identifier Source: org_study_id

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