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NCT Number: NCT07131293

European Registry Study on Lymphatic Interventions

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.

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Key information

Conditions

Lymphatic Disorders Chylothorax Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Hemic and Lymphatic Diseases Intestinal Diseases Lymphatic Abnormalities Lymphatic Diseases Plastic Bronchitis Pleural Diseases Protein Losing Enteropathy Protein-Losing Enteropathies Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Michael R Schmidt, Ass. Professor, MD

PRINCIPAL_INVESTIGATOR

Sanam Safi-Rasmussen, MD

CONTACT

[email protected]

+45 3049 0641

Vibeke Hjortdal, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lymphatic intervention

Procedure

This intervention was made as part of their clinical treatment.

Primary outcomes

  1. 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)

  2. 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)

  3. 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.).

Study contacts

Contact information is provided by the study sponsor or research team.

Sanam Safi-Rasmussen, MD

CONTACT

[email protected]

+4530490641

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bambin Gesù Hospital IRCCS, Rome, Italy
  • Children's University Hospital, Ireland
  • Deutsches Herzzentrum Muenchen
  • Evelina London Children's Hospital
  • Guy's and St Thomas' NHS Foundation Trust
  • Hospital Universitari Vall d'hebron Barcelona, Spain
  • Hospital for Children and Adolescents, University of Helsinki
  • Lund University Hospital
  • UCL Bruxelles
  • UZ Gent, Belgium
  • UZ Leuven, Leuven, Belgium
  • University Hospital Schleswig-Holstein
  • University Hospital, Aachen
  • Universitätsklinikum Erlangen, Erlangen, Bayern, Germany

Registry information

Official study title

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

Acronym: EURO-LYMPH

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 20, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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