NCT02659553

Brief Summary

  1. 1.Clinical impact of graft steatosis on postoperative complications after OLT.
  2. 2.Recommendations to improve outcomes after transplantation of steatotic livers and increase donor pool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

January 11, 2016

Last Update Submit

October 12, 2016

Conditions

Post-operative Complications

Keywords

Liver Transplantation - Steatosis - Fatty Liver

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications rate

    according to the Clavien- Dindo classification system

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Biliary complications: stricture or leakage

    through study completion, an average of 1 year

  • early graft dysfunction (EGD), which is defined as impaired initial allograft function with high peak serum transaminase and persistent high bilirubin levels.

    through study completion, an average of 1 year

  • Primary graft non-function (PNF), which is defined as primary failure of the graft followed by death or re-transplantation within the first post transplantation week.

    through study completion, an average of 1 year

Study Arms (3)

mild steatosis

5% - 30% of hepatocytes have fatty infiltration

Procedure: steatosis

moderate steatosis

30% - 60% of hepatocytes have fatty infiltration

Procedure: steatosis

No steatosis

No or less than 5% of hepatocytes have fatty infiltration

Procedure: steatosis

Interventions

steatosisPROCEDURE

Liver Transplantation with graft steatosis

No steatosismild steatosismoderate steatosis

Eligibility Criteria

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

All adult patients candidate for liver transplantation are included in this study

You may qualify if:

  • All adult patients candidates for liver transplantation are included in this study

You may not qualify if:

  • Pediatric patients are excluded.
  • Re- transplanted patients.
  • cases with no histopathological examination records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polytechnic university of Marche

Ancona, AN, 60126, Italy

Location

Related Publications (6)

  • Nocito A, El-Badry AM, Clavien PA. When is steatosis too much for transplantation? J Hepatol. 2006 Oct;45(4):494-9. doi: 10.1016/j.jhep.2006.07.017. Epub 2006 Jul 31. No abstract available.

    PMID: 16919359RESULT

  • El-Badry AM, Jang JH, Elsherbiny A, Contaldo C, Tian Y, Raptis DA, Laczko E, Moritz W, Graf R, Clavien PA. Chemical composition of hepatic lipids mediates reperfusion injury of the macrosteatotic mouse liver through thromboxane A(2). J Hepatol. 2011 Dec;55(6):1291-9. doi: 10.1016/j.jhep.2011.04.019. Epub 2011 May 19.

    PMID: 21703192RESULT

  • Trevisani F, Colantoni A, Caraceni P, Van Thiel DH. The use of donor fatty liver for liver transplantation: a challenge or a quagmire? J Hepatol. 1996 Jan;24(1):114-21. doi: 10.1016/s0168-8278(96)80195-4. No abstract available.

    PMID: 8834034RESULT

  • Lee JY, Kim KM, Lee SG, Yu E, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Prevalence and risk factors of non-alcoholic fatty liver disease in potential living liver donors in Korea: a review of 589 consecutive liver biopsies in a single center. J Hepatol. 2007 Aug;47(2):239-44. doi: 10.1016/j.jhep.2007.02.007. Epub 2007 Mar 6.

    PMID: 17400323RESULT

  • McCormack L, Dutkowski P, El-Badry AM, Clavien PA. Liver transplantation using fatty livers: always feasible? J Hepatol. 2011 May;54(5):1055-62. doi: 10.1016/j.jhep.2010.11.004. Epub 2010 Nov 13.

    PMID: 21145846RESULT

  • Machado MV, Cortez-Pinto H. Non-invasive diagnosis of non-alcoholic fatty liver disease. A critical appraisal. J Hepatol. 2013 May;58(5):1007-19. doi: 10.1016/j.jhep.2012.11.021. Epub 2012 Nov 23.

    PMID: 23183525RESULT

Study Officials

  • Alaa A. Redwan, Professor

    Sohag University

    STUDY DIRECTOR

  • Marco Vivarelli, Professor

    Università Politecnica delle Marche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 20, 2016

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

IT(1)