European Registry Study on Lymphatic Interventions (EURO-LYMPH)

Rigshospitalet

Status: Enrolling

Conditions: Lymphatic Abnormalities; Chylothorax; Protein Losing Enteropathy; Plastic Bronchitis; Lymphatic Disorders

Treatments: Procedure: Lymphatic intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07131293

R-25051744

Details and patient eligibility

About

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.

Full description

This is a prospective, multicenter observational study with retrospective components. The study population includes patients who have undergone or are undergoing lymphatic imaging diagnostics and lymphatic interventions at participating centers across Europe. Patients are included both retrospectively (from medical records) and prospectively as part of their routine clinical care.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

500 participants in 1 patient group

Lymph intervention

Treatment:

Procedure: Lymphatic intervention