Clinical outcome and Quality of Life of multimodal treatment of venous malformations of the body

Phase 1

Recruiting

Conditions: Q27.8
Q74.8
Q87
Other specified congenital malformations of peripheral vascular system
Other specified congenital malformations of limb(s)
Other specified congenital malformation syndromes affecting multiple systems

Registration Number: DRKS00024906

Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

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

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 <50.000 / µl
- aPTT > 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Therapeutic efficiency and clinical outcome of the selected therapeutic concept for venous malformation treatment at 12, 24, 36 months after completion of invasive treatment:<br>- 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)<br>- Radiological assessment