European Registry Study on Lymphatic Interventions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRigshospitalet, Denmark

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

500 Participants
are divided into 1 treatment group

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