About this trial
This European multicenter observational study aims to evaluate the real-world use, timing, and outcomes of lymphatic interventions in patients with congenital heart disease and/or primary lymphatic disorders. The study will examine the effectiveness of diagnostic imaging and interventional techniques, such as lymphatic embolization, in improving clinical symptoms, biomarkers, and fluid-related complications. The central question is whether early diagnosis and targeted intervention can lead to clinically meaningful improvements and reduced need for reintervention. Data collected retrospectively and prospectively from participating centers will help identify predictors of outcome, assess disease severity, and inform standardized diagnostic and therapeutic pathways across Europe.
Eligibility criteria
Qualifiers
Patients of any age with a confirmed central lymphatic disorder, either in the context of CHD or as a primary lymphatic disorder, verified through lymphatic diagnostics (e.g. lymphatic imaging or relevant biomarkers).
Patients who have undergone, or are undergoing, diagnostic lymphatic imaging and/or interventional procedures for their lymphatic disorder.
Patients who are receiving, or have received, conservative (non-interventional) management for their lymphatic disorder.
Disqualifiers
Patients with isolated peripheral lymphatic disorders not involving the central lymphatic system.
Patients with acute postoperative iatrogenic chylothorax (<3-4 weeks duration and not requiring intervention).
Patients without sufficient clinical documentation to confirm diagnosis, treatment, or follow-up.
Patients who decline, or whose legal guardians decline, to provide informed consent (for prospective inclusion).
Trial design
Treatments tested in this trial
- Lymphatic intervention
Treatment groups
Sponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
UZ Leuven, Leuven, Belgium
Collaborator
UCL Bruxelles
Collaborator
Lund University Hospital
Collaborator
University Hospital Schleswig-Holstein
Collaborator
University Hospital, Aachen
Collaborator
Deutsches Herzzentrum Muenchen
Collaborator
Universitätsklinikum Erlangen, Erlangen, Bayern, Germany
Collaborator
UZ Gent, Belgium
Collaborator
Hospital for Children and Adolescents, University of Helsinki
Collaborator
Hospital Universitari Vall d'hebron Barcelona, Spain
Collaborator
Children's University Hospital, Ireland
Collaborator
Evelina London Children's Hospital
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Bambin Gesù Hospital IRCCS, Rome, Italy
Collaborator