Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
- Conditions
- Hepatic Artery ThrombosisPediatric ALLHepatic Artery StenosisLiver Transplant; Complications
- Registration Number
- NCT05818644
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft survival 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.
Patient survival 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 Outcome Measures
Name Time Method Incidence 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.
Technical success 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.
Intra- and post-procedural complications 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.
Primary and secondary patency 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.
Anticoagulant therapy after transplantation and after interventions 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.
Center specific screening protocol 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.
Center specific diagnostic criteria 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.
Center specific radiological follow up 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.
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands