Peripheral venous malformations
Conditions
Interventions
Test group:Ethanol sclerotherapy
Sponsors
Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical trial, sign the ICF, understand and follow the study procedures; 2. Aged 18-65 years old on the date of signing the informed consent, regardless of gender; 3. Body mass index (BMI, calculated by BMI = weight [kg]/ height 2 [m2]) within the range of 18.5~28.0 kg/m2 (including boundary values); 4. Venous malformations diagnosed by magnetic resonance imaging (ISSVA, 2018) with the following conditions: (1) Common venous malformations of the tongue; (2) Single lesion; (3) The lesion can be measured under MRI (the shortest diameter of the lesion is >= 10 mm), the contour is clear, and the maximum diameter line is = 30 g/L; (3) Creatinine clearance =50 mL/min as calculated from institutional standard practice assessment (based on the Cockcroft-Gault formula, see Appendix 2).
Exclusion criteria
Exclusion criteria: 1. Patients with any other type of vascular malformations, such as capillary malformations, arteriovenous malformations, and lymphatic malformations; 2. Venous malformations involving the gastrointestinal tract, muscles, bones, joints, or nervous system; 3. Patients with mixed, complex venous malformations or venous malformations with other lesions (e.g., capillary-venous malformations, lymphatic-venous malformations, capillary-lymphatic-venous malformations, capillary-venous arteriovenous malformations, capillary-lymphatic-venous arteriovenous malformations, warty venous malformations, familial cutaneous mucous venous malformations, blue erases Blister nevus syndrome, spherical cell venous malformation, Klippel-Trenaunay syndrome, and Maffucci syndrome); 4. Patients with deep venous malformations whose lesions could not be reached by a percutaneous puncture; 5. Patients with extensive superficial venous malformations assessed in studies as having a high risk of skin necrosis after treatment; 6. The presence of intracranial venous malformations in the communicating branches of the vessels; 7. The lesions were located at the base of the tongue, the bottom of the mouth, the larynx, the pharynx, the parapharynx, the soft palate and neck, etc. To maintain the patency of the upper respiratory tract, it was estimated that prophylactic tracheotomy was required before surgery, emergency tracheotomy was needed during surgery, or tracheal intubation was reserved for >= 48 hours after surgery. 8. Patients with an allergic history of iodine contrast agent and ethanol; 9. Actively infected persons: (1) Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; During the screening period, subjects who are HBV surface antigen (HBsAg) positive and HCV antibody positive shall be tested for HBV DNA and HCV RNA. Subjects with HBV DNA = 160 mmHg and diastolic blood pressure >= 110 mmHg); (6) Uncontrolled diabetes, thyroid disease, or other endocrine system disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| The size of lesion;Clinical Symptom Score;Overall efficacy; | — |
Countries
China
Contacts
Public ContactDeming Wang
Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital
Outcome results
None listed