European Registry Study on Lymphatic Interventions

Recruiting

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

• Registration Number: NCT07131293
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-19
• Study First Posted: 2025-08-20
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-22
• Study Start: 2025-09-01
• Primary Completion: 2030-08
• Study Completion: 2030-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients of any age, with primary lymphatic disorder and/or CHD, who have a confirmed central lymphatic disorder diagnosed on lymphatic imaging (T2-weighted MRL and/or DCMRL).
• Patients who have undergone or are undergoing diagnostic imaging (T2-weighted MRL and/or DCMRL) and/or interventional procedures for their lymphatic disorder.
• Patients who are receiving or have received conservative (non-interventional) management for their lymphatic disorder.
• Written informed consent has been obtained from the patient or their legal guardian.

Exclusion Criteria

• Patients with isolated peripheral lymphatic disorders (e.g., primary lymphedema of the limbs, lymphangiomatosis) without central lymphatic system involvement as confirmed by lymphatic imaging.
• Patients with iatrogen chylothorax and without evidence of central lymphatic abnormality on imaging.
• Patients without diagnostic lymphatic imaging (T2-weighted MRL and/or DCMRL).
• Patients who decline or are unable to provide informed consent (or whose legal guardians decline on their behalf).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Symptoms Following Lymphatic Intervention, assessed by:	From time of treatment to yearly follow-up up to 5 years.	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	From time of treatment to yearly follow-up up to 5 years.	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:	From time of treatment to yearly follow-up up to 5 years.	≥50% reduction in presenting symptoms and/or ≥20% improvement in key biomarkers (e.g., serum albumin, lymphocyte count etc.).

Trial Locations

Locations (1)

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark