NCT02203409

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

8.1 years

First QC Date

July 23, 2014

Last Update Submit

January 13, 2022

Conditions

Liver Tumor

Keywords

liver tumorTwo stage hepatectomyHypertrophylaparoscopyALPPS

Outcome Measures

Primary Outcomes (1)

  • Safety of the procedure defined as the incidence of postoperative complications and mortality

    within the first 90 days after the first stage

Secondary Outcomes (1)

  • survival rate

    3 years

Study Arms (1)

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

Procedure: Laparoscopic ALPPS

Interventions

Laparoscopic ALPPSPROCEDURE

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

Laparoscopic ALPPS group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, 400038, China

RECRUITING

Related Publications (11)

  • 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.

    PMID: 15869140BACKGROUND

  • 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.

    PMID: 19367466BACKGROUND

  • 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.

    PMID: 17980321BACKGROUND

  • 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.

    PMID: 23188224BACKGROUND

  • 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.

    PMID: 22330038BACKGROUND

  • 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.

    PMID: 22903531BACKGROUND

  • 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.

    PMID: 23288719BACKGROUND

  • 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.

    PMID: 22895355BACKGROUND

  • 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.

    PMID: 8759671BACKGROUND

  • 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: 23099728BACKGROUND

  • 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.

    PMID: 11420484BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularHypertrophy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shuguo Zheng

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

    STUDY DIRECTOR

Central Study Contacts

Shuguo Zheng

CONTACT

86-13508308676shuguozh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 29, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

January 14, 2022

Record last verified: 2022-01

Locations

CN(1)