European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Symptoms Following Lymphatic Intervention, assessed by:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Symptoms Following Lymphatic Intervention, assessed by:
时间窗: 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
时间窗: 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:
时间窗: 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.).
次要结局
未报告次要终点
研究者
Sanam Safi-Rasmussen
Sanam Safi-Rasmussen, MD & PhD-fellow
Rigshospitalet, Denmark