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Impact of Graft Steatosis on Post-operative Complications After Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659553
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
Università Politecnica delle Marche
Information provided by (Responsible Party):
Emad Ali Ahmed Ali, Sohag University

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

Condition or disease Intervention/treatment
Post-operative Complications Procedure: steatosis

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Study Type : Observational
Actual Enrollment : 271 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Graft Steatosis on Post-operative Complications After Liver Transplantation
Study Start Date : January 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
mild steatosis
5% - 30% of hepatocytes have fatty infiltration
Procedure: steatosis
Liver Transplantation with graft steatosis

moderate steatosis
30% - 60% of hepatocytes have fatty infiltration
Procedure: steatosis
Liver Transplantation with graft steatosis

No steatosis
No or less than 5% of hepatocytes have fatty infiltration
Procedure: steatosis
Liver Transplantation with graft steatosis




Primary Outcome Measures :
  1. Post-operative complications rate [ Time Frame: through study completion, an average of 1 year ]
    according to the Clavien- Dindo classification system


Secondary Outcome Measures :
  1. Biliary complications: stricture or leakage [ Time Frame: through study completion, an average of 1 year ]
    the outcome will be measured retrospectively from the hospital records and prospectively in the recent cases of transplantation

  2. early graft dysfunction (EGD), which is defined as impaired initial allograft function with high peak serum transaminase and persistent high bilirubin levels. [ Time Frame: through study completion, an average of 1 year ]
    the outcome will be measured retrospectively from the hospital records and prospectively in the recent cases of transplantation

  3. 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. [ Time Frame: through study completion, an average of 1 year ]
    the outcome will be measured retrospectively from the hospital records and prospectively in the recent cases of transplantation



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients candidate for liver transplantation are included in this study
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659553


Locations
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Italy
Polytechnic university of Marche
Ancona, AN, Italy, 60126
Sponsors and Collaborators
Sohag University
Università Politecnica delle Marche
Investigators
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Study Director: Alaa A. Redwan, Professor Sohag University
Study Director: Marco Vivarelli, Professor Università Politecnica delle Marche
Publications of Results:
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Responsible Party: Emad Ali Ahmed Ali, Principal Investigator, Sohag University
ClinicalTrials.gov Identifier: NCT02659553    
Other Study ID Numbers: 28/9/2014
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Emad Ali Ahmed Ali, Sohag University:
Liver Transplantation - Steatosis - Fatty Liver
Additional relevant MeSH terms:
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Fatty Liver
Postoperative Complications
Liver Diseases
Digestive System Diseases
Pathologic Processes