Peripheral venous malformations
Conditions
Interventions
Radiopaque ethanol injection treatment group:Treating by radiopaque ethanol injection
Absolute ethanol injection treatment group:Treating by absolute ethanol injection
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical trial and sign the ICF, understand and follow the study procedures; 2. >=18 years old and =1.0 cm), the contour is clear, and the maximum diameter =30.0 g/L; c) Creatinine clearance calculated according to institutional standard practice assessments>=50.0 mL/min (according to the Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Patients with any other type of vascular malformation, such as: microvenous malformation, arteriovenous malformation, lymphatic malformation; 2. Venous malformations involving the gastrointestinal tract, muscles, bones, joints or nervous system; 3. Patients with mixed, complex venous malformations or venous malformations combined with other lesions (such as venule-venous malformations, lymphatic-venous malformations, venules-lymphatic-venous malformations, venules-vein-arteriovenous malformations, venules-lymphatic-vein-arteriovenous malformations, verrucous vein malformations, familial mucocutaneous venous malformations, blue rubber blister nevus syndrome, spherical cell venous malformations, Klippel-Trenaunay syndrome and Maffucci syndrome); 4. Patients with deep venous malformations whose lesions cannot be reached by percutaneous puncture route; 5. Patients with extensive superficial venous malformations with high risk of skin necrosis after treatment as assessed by the investigator; 6. Presence of venous malformations of intracranial vascular communication branches; 7. Patients whose lesions are located at the base of the tongue, floor of the mouth, laryngopharynx, parapharynx, soft palate and neck, etc., in order to maintain the patency of the upper respiratory tract, it is expected that prophylactic tracheostomy is required before surgery, or emergency tracheostomy is required during surgery, or tracheal intubation needs to be retained after surgery >=48 hours; 8. Patients with a history of iodine contrast agent allergy and ethanol allergy; 9. Active Infected Persons: f) Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; g) Study participants who are positive for hepatitis B virus surface antigen (HBsAg) and/or HCV antibody during the screening period must be tested for HBV DNA and/or HCV RNA. Study participants =450 ms for males and > for females). =470 ms, or have QT prolongation syndrome, or have comorbid conditions that may lead to QT prolongation; m) hypertension (systolic blood pressure > = 160 mmHg and/or diastolic blood pressure > = 110 mmHg) that is not well controlled by antihypertensive drugs; n) Uncontrolled diabetes mellitus, thyroid disease, or other endoc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactLixin Su
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed