European Registry Study on Lymphatic Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lymphatic intervention.
- Who it may be relevant to
- Registry conditions: Lymphatic Disorders, Plastic Bronchitis, Protein Losing Enteropathy, Chylothorax. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
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.
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.
Interventions
- Procedure Lymphatic intervention
This intervention was made as part of their clinical treatment.
Primary outcome measures
- Change in Symptoms Following Lymphatic Intervention, assessed by: [Time frame: From time of treatment to yearly follow-up up to 5 years.]
- Change in Objective Biomarkers Following Lymphatic Intervention [Time frame: From time of treatment to yearly follow-up up to 5 years.]
- Composite improvement: [Time frame: From time of treatment to yearly follow-up up to 5 years.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Rigshospitalet, Copenhagen University Hospital — Copenhagen
Identifiers
NCT: NCT07131293 · R-25051744