European registry of lymphatic interventions for people with congenital heart disease or primary lymphatic disorders
European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
This registry will collect how lymphatic imaging and procedures like embolization are used and see if earlier targeted treatment helps people with congenital heart disease or primary lymphatic disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07131293 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter observational registry, with retrospective components, collects real-world data from European centers on patients who have undergone or will undergo central lymphatic imaging and interventions. It captures timing of diagnosis and treatment, clinical symptoms, biomarkers, imaging findings, procedural details such as lymphatic embolization, and outcomes including reintervention rates. The study aims to identify predictors of outcome, stratify disease severity, and compare conservative versus interventional management. Findings will be used to inform standardized diagnostic and therapeutic pathways across participating European centers.
Who should consider this trial
Good fit: Ideal candidates are patients of any age with confirmed central lymphatic disorders—either associated with congenital heart disease or primary lymphatic disease—who have had or will have lymphatic imaging or interventional procedures, or who are managed conservatively.
Not a fit: Patients with isolated peripheral lymphatic disorders, very recent uncomplicated postoperative chylothorax, those without adequate clinical documentation, or those who decline consent are unlikely to benefit from inclusion.
Why it matters
Potential benefit: If successful, this work could lead to earlier, better-targeted lymphatic procedures that reduce fluid-related complications and the need for repeat interventions.
How similar studies have performed: Small case series and single-center reports suggest lymphatic embolization can improve symptoms in selected patients, but large multicenter registry data are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Copenhagen
- Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Sanam Safi-Rasmussen, MD
- Email: sanam.safi-rasmussen@regionh.dk
- Phone: +4530490641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.