European registry of lymphatic interventions for people with congenital heart disease or primary lymphatic disorders
Official title: European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
Run by Copenhagen University Hospital, Rigshospitalet · NCT07131293 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | March 2030 |
| Study ends | March 2030 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07131293 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Small case series and single-center reports suggest lymphatic embolization can improve symptoms in selected patients, but large multicenter registry data are limited.
Who can join: the full rules
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 it's running
-
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Sanam Safi-Rasmussen, MD
- Email: sanam.safi-rasmussen@regionh.dk
- Phone: +4530490641
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.