European Registry Study on Lymphatic Interventions

Rigshospitalet, Denmark500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Lymphatic Disorders Plastic Bronchitis Protein Losing Enteropathy Chylothorax Lymphatic Abnormalities

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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)

Time frame: From time of treatment to yearly follow-up up to 5 years.

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)

Time frame: From time of treatment to yearly follow-up up to 5 years.

Composite improvement:

≥50% reduction in presenting symptoms and/or ≥20% improvement in key biomarkers (e.g., serum albumin, lymphocyte count etc.).

Time frame: From time of treatment to yearly follow-up up to 5 years.

European Registry Study on Lymphatic Interventions

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts