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Clinical Trials in Denmark / NCT07131293
Recruiting Observational

European Registry Study on Lymphatic Interventions

NCT07131293 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2026-02-01
Last updated
2026-01-21

Condition(s) studied

Lymphatic DisordersPlastic BronchitisProtein Losing EnteropathyChylothoraxLymphatic Abnormalities

Investigational drug(s) / intervention(s)

Lymphatic intervention

Lymphatic intervention: This intervention was made as part of their clinical treatment.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131293 on ClinicalTrials.gov ↗ ← All trials in Denmark