European Registry Study on Lymphatic Interventions

NCT07131293 | Recruiting

• 1 other identifier: R-25051744
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphatic Disorders; Plastic Bronchitis; Protein Losing Enteropathy; Chylothorax; Lymphatic Abnormalities

Keywords

Lymphatic complications; Multicenter study; Plastic bronchitis; Protein Losing Enteropathy; Chylothorax

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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.).

  From time of treatment to yearly follow-up up to 5 years.

Study Arms (1)

Lymph intervention

Procedure: Lymphatic intervention

Interventions

Lymphatic intervention PROCEDURE

This intervention was made as part of their clinical treatment.

Lymph intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Lymphatic Diseases; Protein-Losing Enteropathies; Chylothorax; Lymphatic Abnormalities

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pleural Diseases; Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vibeke E Hjortdal, Professor

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Michael Rahbek Schmidt, Ass. professor, PhD, DMSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Central Study Contacts

Sanam Safi-Rasmussen, MD

CONTACT

+4530490641; sanam.safi-rasmussen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sanam Safi-Rasmussen, MD & PhD-fellow

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)