Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children

Pediatric ALL Clinical Trial

— HEPATIC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05818644
• Other study ID #: 17033
• Status: Enrolling by invitation
• Start date: September 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Liver Transplant; Complications
• Pediatric ALL
• Thrombosis

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (36)

Lead Sponsor

Collaborator

University Medical Center Groningen

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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