Actively Recruiting

All Genders
ID07131293

European Registry Study on Lymphatic Interventions Towards Standardized Care in CHD-Related Lymphatic Disorders

Led by Rigshospitalet, Denmark · Updated on 2026-01-21

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

U

UZ Leuven, Leuven, Belgium

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a European multicenter observational study to understand the real-world use, timing, and outcomes of lymphatic interventions in patients with congenital heart disease and primary lymphatic disorders. The study focuses on assessing how early diagnosis and targeted lymphatic treatments may improve clinical symptoms, biomarkers, and complications related to fluid imbalance. Data collected both retrospectively and prospectively from participating centers aims to identify outcome predictors, evaluate disease severity, and support standardized care across Europe. The study includes patients who have undergone or are undergoing lymphatic imaging diagnostics and interventions, as well as those managed conservatively without intervention. Lymphatic interventions, like lymphatic embolization, are part of the clinical treatments being observed. Patients are included based on past medical records and ongoing routine care at specialized centers. Participants will be monitored from the time of treatment and followed yearly for up to five years to evaluate changes in symptoms, objective biomarkers, and overall clinical improvement. The study collects extensive clinical data from diagnostic procedures, interventions, and routine care to support outcome assessment. This long-term observation will help researchers understand the benefits and timing of lymphatic interventions and improve future diagnostic and therapeutic pathways.

CONDITIONS

Brief Title

European Registry Study on Lymphatic Interventions

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of any age with a confirmed central lymphatic disorder related to congenital heart disease or primary lymphatic disorder, verified by lymphatic imaging or biomarkers.
  • Patients who have undergone or are undergoing diagnostic lymphatic imaging and/or interventional procedures.
  • Patients receiving or who have received conservative (non-interventional) management for their lymphatic disorder.
Not Eligible

You will not qualify if you...

  • Patients with isolated peripheral lymphatic disorders not involving the central lymphatic system.
  • Patients with acute postoperative iatrogenic chylothorax lasting less than 3-4 weeks and not requiring intervention.
  • Patients without sufficient clinical documentation to confirm diagnosis, treatment, or follow-up.
  • Patients or their legal guardians who decline to provide informed consent for prospective participation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Varies depending on clinical care

Participants undergo lymphatic imaging diagnostics as part of their clinical care to assess lymphatic disorders.

Implementation

Duration - Varies depending on clinical care

Participants who undergo lymphatic interventions as part of their routine clinical treatment are observed.

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for changes in symptoms and objective biomarkers following lymphatic intervention for up to 5 years.

Yearly visits for follow-up assessments

Trial Site Locations

Total: 1 location

1

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark, 2100

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Research Team

S

Sanam Safi-Rasmussen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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