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Completed

NCT Number: NCT05818644

Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children

The goal of this observational study is to investigate the incidence, current management practices, and outcomes in pediatric patients with HAC after liver transplantation.

Research question:

* What are the overall incidence of HAC and the effectiveness of all treatment strategies for HAC after pediatric LT? * What are the current management practices in the experience of centers, anticoagulant therapy, screening protocol, and assessment criteria for HAC after pediatric LT?

The burden of participation is considered to be minimal, and limited to the questionnaires.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver transplantation between January 1st 2002 and January 1st 2022, diagnoses of HAC after LT
  • The age of the patient is below 18 years at the time of diagnosis and intervention
  • The date of diagnosis of HAC or intervention was before January 1st 2023. HAC occurring after first or subsequent LTs are included.

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

  1. Graft survival

    Time frame: 1-1-2001 and 1-1-2023

    Graft survival is defined as a functioning graft from transplantation to the end of follow-up data, re-transplantation, or death, whichever occurs first.

  2. Patient survival

    Time frame: 1-1-2001 and 1-1-2023

    Patient survival is defined from the date of the primary LT until date of death. Causes of re-transplantation or death will be recorded.

Secondary outcomes

  1. Technical success

    Time frame: 1-1-2001 and 1-1-2023

    Technical success is defined as the success of the intervention in re-establishing the arterial blood flow to the liver and will be assessed by each individual center.

  2. Primary and secondary patency

    Time frame: 1-1-2001 and 1-1-2023

    Primary patency is defined as the time between the index treatment and re-intervention intended to restore patency in patients with a restenosis or re-occlusion. Secondary patency is the time between the index treatment and failure to re-establish flow by means of re-intervention. In case of re-transplantation or death due to other reasons, the patients will be censored if the treated vessel is patent. Kaplan-Meier curves will be plotted to visualize primary and secondary patency rates at various times after treatment for HAC, including 1, 3, 5, 10, 15 and 20 years.

  3. Intra- and post-procedural complications

    Time frame: 1-1-2001 and 1-1-2023

    Procedural complications will be categorized into two main groups: transplant complications and procedural complications related to endovascular or surgical revascularization for HAC. Within these groups, intra-procedural complications predominantly consist of vascular issues, such as thrombosis, stenosis, compression, dissection, and rupture. In contrast, post-procedural complications encompass a broader range of issues, such as infection, rejection, bleeding, and vascular and biliary complications, including anastomotic stricture, non-anastomotic strictures, bile leak, biloma, or cholangitis. Re-interventions addressing both intra- and post-procedural complications will also be recorded.

  4. Anticoagulant therapy after transplantation and after interventions

    Time frame: 1-1-2001 and 1-1-2023

    Anticoagulant therapy after transplantation and after interventions for HAC will be assessed according to the management practices of each participating site (center specific) and individual patient data (patient specific). Details about each anticoagulation regimen, including the specific anticoagulant, duration of anticoagulation, and upper and lower limits of target values, such as international normalized ratio, anti-factor Xa, and activated partial thromboplastin time, will be recorded. Patient-specific management will be documented for patients with HAC.

  5. Center specific screening protocol

    Time frame: 1-1-2001 and 1-1-2023

    Local screening protocols to assess HAC after LT, such as the routine post-operative Doppler ultrasound policy, will be documented. Whether HAC screening is consistent for patients with and without risk factors will also be examined. The frequency of preferred radiological screening investigations within 2 weeks after LT will be determined, considering various risk factors.

  6. Center specific diagnostic criteria

    Time frame: 1-1-2001 and 1-1-2023

    The diagnostic criteria section will cover the types of HAC, non-invasive radiological criteria, and interventional radiological criteria during invasive angiography. The center's definition of technical success after interventional radiological treatment will also be recorded.

  7. Center specific radiological follow up

    Time frame: 1-1-2001 and 1-1-2023

    The radiological follow-up section will assess whether follow-up protocols are the same for all interventions or specific to each intervention type. The imaging methods and frequencies of radiological follow-up for different treatment modalities will be determined. Additionally, the experience years and level of seniority of the interventional radiologist will be recorded.

  8. Incidence

    Time frame: 1-1-2001 and 1-1-2023

    The incidence of HAC will be determined by dividing the total number of patients diagnosed with HAC between 1st of January 2002 and 1st of January 2023, who had undergone LT between 1st of January 2002 and 1st of January 2022, by the total number of patients who underwent LT at pediatric age between 1st of January 2002 and 1st of January 2022. The study will present the overall incidence of HAC during the 20-year period of 2002 to 2022, as well as the incidence during specific 5-year intervals, namely 2002 to 2007, 2007 to 2012, 2012 to 2017, and 2017 to 2022, for each complication.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Amrita Institute of Medical Sciences & Research Center
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Aster CMI Hospital
  • Auckland City Hospital
  • Bambino Gesù Children's Hospital
  • Birmingham Women's and Children's Hospital
  • Children's Hospital Pittsburgh
  • Children's Hospital of Philadelphia
  • Children's Memorial Health Institute
  • Dr Rela Institute and Medical Centre
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Faculty of Medicine & Dentistry, University of Alberta
  • Hannover Medical School
  • Hospital Italiano de Buenos Aires
  • Hospital Santo Antonio
  • Hospital Sirio-Libanes
  • Hôpital Bicêtre
  • J. P. Garrahan Hospital
  • Karolinska Institutet
  • King Faisal Specialist Hospital & Research Center
  • La Paz University Hospital
  • Max Super Speciality Hospital
  • Medical University Innsbruck
  • National University Hospital, Singapore
  • Papa Giovanni XXIII Hospital
  • Primary Children's Hospital
  • Recanati-Miller Transplantation Institute, Mount Sinai Hospital
  • RenJi Hospital
  • Royal Children's Hospital
  • Thomayer University Hospital
  • University Children's Hospital
  • University Hospital, Geneva
  • Universitätsklinikum Hamburg-Eppendorf
  • Vall d'Hebron Barcelona Hospital Campus
  • Wits Donald Gordon Medical Centre
  • Zhejiang University

Registry information

Official study title

Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children: a Multicenter, Retrospective, Observational Study

Acronym: HEPATIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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