Q87
Conditions
Interventions
Group 1: All patients included in this study have the indication for image-guided minimally invasive intervention independent of this study. The indication is based on the relevant guidelines or on th
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical indication for percutaneous sclerotherapy of slow-flow vascular malformation (venous/lymphatic/combined malformation). The indication for intervention in this case must be independent of the presented study. - The localization of the vascular malformation is not or not sufficiently accessible by conventional imaging (sonography and X-ray fluoroscopy). - Previous therapy (surgery, embolization, sclerotherapy) without improvement of symptoms. - Platelets > 50,000/mm3 (50 GPt/l) - INR/PTT 4 years
Exclusion criteria
Exclusion criteria: - Lack of informed consent and/or lack of capacity to consent to the study. - Contraindications to MRI examination, especially implants not suitable for MR, tattoos or piercings, limiting claustrophobia. - Contraindications to contrast agents (only in the case of MR contrast agent use): o Known allergy to MR contrast media. o Higher grade renal insufficiency (GFR 1.5 -fold upper normal value o Presence of an abnormality of blood coagulation. - Patients with high-flow vascular malformations or other vascular abnormalities (vascular tumors). - Concomitant consumptive disease or ECOG > 1. - Contraindications for invasive treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success (degree of devascularization) compared with conventional intervention using sonography and fluoroscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Visualization of vascular malformations during minimally invasive MR-assisted percutaneous sclerotherapy in the context of study-controlled data collection. - Feasibility of the above therapy. - Morbidity and mortality of MR-assisted percutaneous sclerotherapy compared with conventional intervention using sonography and fluoroscopy. - Cost-effectiveness of MR-guided percutaneous sclerotherapy compared with conventional intervention using sonography and X-ray fluoroscopy. - Clinical outcome (subjective grading of symptom severity) compared to conventional intervention by sonography and radioscopy and evaluation of disease-related quality of life by questionnaires (SF-36v2/SF-10) pre- and postintervention after 3, 6 and 12 months. | — |
Countries
Germany
Contacts
Public ContactSchmidt Vanessa
Klinik und Poliklinik für Radiologie
Outcome results
None listed