Q27.8 Q74.8 Q87
Conditions
Interventions
Group 1: Peripheral (i.e. not in the region of the head but on the limbs or trunk) venous malformation has been diagnosed (abbreviated VM). This vascular malformation is a rare clinical picture with v
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
4 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age: > 4 years, < 70 years - Patients with simple peripheral (=extracranial) venous malformations according to the ISSVA (International Society for the Study of Vascular Anomalies) classification. Each patient and the corresponding diagnosis, is discussed in an interdisciplinary board for vascular anomalies before initiation of treatment. Patients with combined vascular malformations and venous malformations associated with other anomalies according to the ISSVA (International Society for the Study of Vascular Anomalies) classification - Patients with first line therapy or patients with previous alternative therapies in whom the previous treatments did not lead to durable symptom improvement - Previous surgery or sclerotherapy are not an exclusion criterion, but these patients will only be included in case of a therapy-free interval of 12 months - Adults and children will be similarly included
Exclusion criteria
Exclusion criteria: Patients with VM located in the central nervous system - Patients with VM located in abdominal parenchymal organs and the gastrointestinal tract - Patients with other high-flow vascular anomalies (e. g. vascular tumors) - Patients who have been previously treated by surgery or sclerotherapy within the last 12 months - Patients with concomitant life-limiting diseases (such as cancer) - Patients with acute inflammatory diseases - Patients with contraindications for invasive treatments o Patients with contrast agent intolerance or renal insufficiency (GFR>30ml/min) o Patients with impaired coagulation status:- Platelet count 50s - INR > 1,5 o Poor general condition with ECOC performance > 1 - Pregnant or breast-feeding women - Inability to access the VM lesion due to anatomical or pathoanatomical reason - Inability of the patient/parents to understand or follow the study protocol e.g. due to impaired mental health status - Patients/parents who refuse to give informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic efficiency and clinical outcome of the selected therapeutic concept for venous malformation treatment at 12, 24, 36 months after completion of invasive treatment: - Physician-reported signs: general appearance (for example swelling, pulsation, pain, thrombosis, coagulopathy, cardiovascular health issues, bleeding) and location-specific signs (for example extremity length discrepancy, physical impairment) - Radiological assessment | — |
Primary
| Measure | Time frame |
|---|---|
| Patient-reported health-related Quality of Life in a multimodal therapy concept for venous malformation treatment at 6 months after completion of invasive treatment. In order to investigate the QoL in a standardized way, established questionnaires (SF-36v2, SF-10) will be used. | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactVanessa F. Schmidt
Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Outcome results
None listed