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.
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.
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).
Participants will be identified from pediatric and adult congenital cardiology and lymphatic referral centers across Europe. The study population includes patients of any age with congenital heart disease (CHD) and associated central lymphatic complications (such as plastic bronchitis, protein-losing enteropathy, or chylothorax), as well as patients with primary central lymphatic disorders. Patients are included from tertiary care institutions that perform lymphatic imaging and/or interventions and will be enrolled retrospectively from existing clinical records and prospectively during routine care.
Cohort
Other
Lymphatic intervention
Procedure/SurgeryThis intervention was made as part of their clinical treatment.
Change in Symptoms Following Lymphatic Intervention, assessed by:
Patient-reported or physician-assessed symptoms (e.g., cough, diarrhea, dyspnea) will be categorized as normalized, improved, unchanged, or worsened compared to baseline. Unit of Measure: Symptom status category (normalized / improved / unchanged / worsened)
Change in Objective Biomarkers Following Lymphatic Intervention
Objective clinical findings (e.g., serum albumin level, lymphocyte count, fluid accumulation) will be categorized as normalized, improved, unchanged, or worsened compared to baseline. Unit of Measure: Biomarker status category (normalized / improved / unchanged / worsened)
Composite improvement:
≥50% reduction in presenting symptoms and/or ≥20% improvement in key biomarkers (e.g., serum albumin, lymphocyte count etc.).
Click on the lead sponsor to view all of their trials.
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
