An observational study in Lymphatic Disorders, Plastic Bronchitis and Protein Losing Enteropathy, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.
This study's planned enrollment of 500 is above the median of 56 across 13 observational studies indexed under Lymphatic Abnormalities.
Browse Lymphatic Abnormalities studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Compared within Lymphatic Abnormalities, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphatic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Participants will be identified from pediatric and adult congenital cardiology and lymphatic referral centers across Europe. The study population includes patients of any age with congenital heart disease (CHD) and associated central lymphatic complications (such as plastic bronchitis, protein-losing enteropathy, or chylothorax), as well as patients with primary central lymphatic disorders. Patients are included from tertiary care institutions that perform lymphatic imaging and/or interventions and will be enrolled retrospectively from existing clinical records and prospectively during routine care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Lymphatic intervention
This intervention was made as part of their clinical treatment.
Change in Symptoms Following Lymphatic Intervention, assessed by:
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)
Time frame: From time of treatment to yearly follow-up up to 5 years.
Change in Objective Biomarkers Following Lymphatic Intervention
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)
Time frame: From time of treatment to yearly follow-up up to 5 years.
Composite improvement:
≥50% reduction in presenting symptoms and/or ≥20% improvement in key biomarkers (e.g., serum albumin, lymphocyte count etc.).
Time frame: From time of treatment to yearly follow-up up to 5 years.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Mar 2030, 49 months later.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.