Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children (HEPATIC)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pediatric ALL; Liver Transplant; Complications; Hepatic Artery Thrombosis; Hepatic Artery Stenosis

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen
    • Principal Investigator: Reinoud PH Bokkers, MD, phD
    • Principal Investigator: Hubert PJ van der Doef, MD, phD
    • Sub-Investigator: Weihao Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any pediatric patient diagnosed with HAC and treated for HAC (at age <18 years) after pediatric liver transplantation between 1-1-2002 and 1-1-2023

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Conservative treatment
Surgical revascularization
Endovascular revascularization
Re-transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft survival	Graft survival is defined as a functioning graft from transplantation to the end of follow-up data, re-transplantation, or death, whichever occurs first.	1-1-2001 and 1-1-2023
Patient survival	Patient survival is defined from the date of the primary LT until date of death. Causes of re-transplantation or death will be recorded.	1-1-2001 and 1-1-2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	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.	1-1-2001 and 1-1-2023
Primary and secondary patency	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.	1-1-2001 and 1-1-2023
Intra- and post-procedural complications	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.	1-1-2001 and 1-1-2023
Anticoagulant therapy after transplantation and after interventions	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.	1-1-2001 and 1-1-2023
Center specific screening protocol	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.	1-1-2001 and 1-1-2023
Center specific diagnostic criteria	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.	1-1-2001 and 1-1-2023
Center specific radiological follow up	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.	1-1-2001 and 1-1-2023
Incidence	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.	1-1-2001 and 1-1-2023

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Pathological Conditions, Anatomical; Thrombosis; Constriction, Pathologic
• Other Study ID Numbers: 17033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No