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Liver TumorNCT02203409

Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy

An observational study of Liver Tumor, run by Shuguo Zheng, MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Liver Tumor
What is being tested?
Laparoscopic ALPPS
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteChina
Study dates
Jul 2014to Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 30

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Shuguo Zheng contact

86-13508308676

shuguozh@gmail.com

China1 site, 1 recruiting

  • Southwest Hospital

    Chongqing, 400038

    Shuguo Zheng, Professor, 86-13508308676, shuguozh@gmail.com

    Recruiting

Other trials in China

About this study

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.

Read the detailed 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.

Conditions
Liver Tumor
Being tested
Laparoscopic ALPPS
Keywords
liver tumor, Two stage hepatectomy, Hypertrophy, laparoscopy, ALPPS
Medical subject headings
Carcinoma, Hepatocellular, Hypertrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic ALPPSProcedure or surgery

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

Study groups in NCT02203409
Study groupRoleWhat they receive
Laparoscopic ALPPS groupPatients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach
Receives: Procedure: Laparoscopic ALPPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of the procedure defined as the incidence of postoperative complications and mortality

    Measured: within the first 90 days after the first stage

Secondary outcomes (1)

  1. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203409
Sponsor's protocol ID
SWHZSG005
Other IDs
30972948
Status last verified
Jan 2022
First submitted
23 Jul 2014
Last updated
14 Jan 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15869140

  • 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.

    PubMed 19367466

  • 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.

    PubMed 17980321

  • 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.

    PubMed 23188224

  • 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.

    PubMed 22330038

  • 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.

    PubMed 22903531

  • 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.

    PubMed 23288719

  • 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.

    PubMed 22895355

  • 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.

    PubMed 8759671

  • 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.

    PubMed 23099728

  • 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.

    PubMed 11420484

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Tumor, run by Shuguo Zheng, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shuguo Zheng (86-13508308676, shuguozh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of the procedure defined as the incidence of postoperative complications and mortality (time frame: within the first 90 days after the first stage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02203409, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.

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