European Registry Study on Lymphatic Interventions
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lymphatic intervention.
- Кому может быть актуально
- Состояния в реестре: Lymphatic Disorders, Plastic Bronchitis, Protein Losing Enteropathy, Chylothorax. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
European Registry Study on Lymphatic Interventions: Towards Standardized Care in CHD-Related Lymphatic Disorders
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Lymphatic intervention
This intervention was made as part of their clinical treatment.
Первичные конечные точки
- Change in Symptoms Following Lymphatic Intervention, assessed by: [Срок оценки: From time of treatment to yearly follow-up up to 5 years.]
- Change in Objective Biomarkers Following Lymphatic Intervention [Срок оценки: From time of treatment to yearly follow-up up to 5 years.]
- Composite improvement: [Срок оценки: From time of treatment to yearly follow-up up to 5 years.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Дания · 1 центр
- Rigshospitalet, Copenhagen University Hospital — Copenhagen
Идентификаторы
NCT: NCT07131293 · R-25051744