European Registry Study on Lymphatic Interventions

NCT ID: NCT07131293

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2030-03-31

Brief Summary

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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

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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

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Lymphatic Disorders Plastic Bronchitis Protein Losing Enteropathy Chylothorax Lymphatic Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Lymph intervention

Lymphatic intervention

Intervention Type PROCEDURE

This intervention was made as part of their clinical treatment.

Interventions

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Lymphatic intervention

This intervention was made as part of their clinical treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UZ Leuven, Leuven, Belgium

UNKNOWN

Sponsor Role collaborator

UCL Bruxelles

UNKNOWN

Sponsor Role collaborator

Lund University Hospital

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

University Hospital, Aachen

OTHER

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role collaborator

Universitätsklinikum Erlangen, Erlangen, Bayern, Germany

UNKNOWN

Sponsor Role collaborator

UZ Gent, Belgium

UNKNOWN

Sponsor Role collaborator

Hospital for Children and Adolescents, University of Helsinki

UNKNOWN

Sponsor Role collaborator

Hospital Universitari Vall d'hebron Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Children's University Hospital, Ireland

OTHER

Sponsor Role collaborator

Evelina London Children's Hospital

UNKNOWN

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

Bambin Gesù Hospital IRCCS, Rome, Italy

UNKNOWN

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sanam Safi-Rasmussen

Sanam Safi-Rasmussen, MD & PhD-fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vibeke E Hjortdal, Professor

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Michael Rahbek Schmidt, Ass. professor, PhD, DMSc

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sanam Safi-Rasmussen, MD

Role: CONTACT

+4530490641

Facility Contacts

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Sanam Safi-Rasmussen, MD

Role: primary

+45 3049 0641

Other Identifiers

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R-25051744

Identifier Type: -

Identifier Source: org_study_id

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