Lymphatic DisordersEURO-LYMPHNCT07131293
European Registry Study on Lymphatic Interventions
An observational study of Lymphatic Disorders and Plastic Bronchitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphatic Disorders, Plastic Bronchitis, Protein Losing Enteropathy
- What is being tested?
- Lymphatic intervention
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to Mar 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
Sanam Safi-Rasmussen, MD, +45 3049 0641, sanam.safi-rasmussen@regionh.dk
Vibeke Hjortdal, Professor
About this study
Official title: European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
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.
Read the detailed description
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.
- Conditions
- Lymphatic Disorders, Plastic Bronchitis, Protein Losing Enteropathy, Chylothorax, Lymphatic Abnormalities
- Being tested
- Lymphatic intervention
- Keywords
- Lymphatic complications, Multicenter study, Plastic bronchitis, Protein Losing Enteropathy, Chylothorax
- Medical subject headings
- Lymphatic Diseases, Protein-Losing Enteropathies, Chylothorax, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic interventionProcedure or surgery
This intervention was made as part of their clinical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Lymph intervention | Not described Receives: Procedure: Lymphatic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.).
Measured: From time of treatment to yearly follow-up up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Feb 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic DisordersStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- UZ Leuven, Leuven, Belgium, UCL Bruxelles, Lund University Hospital, University Hospital Schleswig-Holstein, University Hospital, Aachen, Deutsches Herzzentrum Muenchen, Universitätsklinikum Erlangen, Erlangen, Bayern, Germany, University Hospital, Ghent, Hospital for Children and Adolescents, University of Helsinki, Hospital Universitari Vall d'hebron Barcelona, Spain, Children's University Hospital, Ireland, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, Bambin Gesù Hospital IRCCS, Rome, Italy
- Responsible party
- Principal investigator, Sanam Safi-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke E Hjortdal, Professor, Study director, Copenhagen University Hospital, RigshospitaletMichael Rahbek Schmidt, Ass. professor, PhD, DMSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131293
- Sponsor's protocol ID
- R-25051744
- Acronym
- EURO-LYMPH
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
- ClinicalTrials.gov ID
- NCT07131293
- Acronym / sponsor ID
- EURO-LYMPH / R-25051744
- Conditions
- Lymphatic Disorders, Plastic Bronchitis, Protein Losing Enteropathy, Chylothorax, Lymphatic Abnormalities
- Keywords
- Lymphatic complications, Multicenter study, Plastic bronchitis, Protein Losing Enteropathy, Chylothorax
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- UZ Leuven, Leuven, Belgium, UCL Bruxelles, Lund University Hospital, University Hospital Schleswig-Holstein, University Hospital, Aachen, Deutsches Herzzentrum Muenchen, Universitätsklinikum Erlangen, Erlangen, Bayern, Germany, University Hospital, Ghent, Hospital for Children and Adolescents, University of Helsinki, Hospital Universitari Vall d'hebron Barcelona, Spain, Children's University Hospital, Ireland, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, Bambin Gesù Hospital IRCCS, Rome, Italy
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymph intervention | – | Procedure: Lymphatic intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphatic interventionThis intervention was made as part of their clinical treatment. | Procedure or surgery | Lymph intervention |
Primary outcome
Change in Symptoms Following Lymphatic Intervention, assessed by:
Time frame: 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
Time frame: 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:
Time frame: 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.).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vibeke E Hjortdal, Professor study director
Copenhagen University Hospital, Rigshospitalet
Michael Rahbek Schmidt, Ass. professor, PhD, DMSc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Disorders and Plastic Bronchitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanam Safi-Rasmussen, MD (+4530490641, sanam.safi-rasmussen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptoms Following Lymphatic Intervention, assessed by: (time frame: From time of treatment to yearly follow-up up to 5 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.