title: Treatment of venous malformations: first experience with a new sclerosing agent--a multicenter study.
abstract: OBJECTIVE
  To study the efficacy and safety of a new sclerosing gel of absolute ethanol in the percutaneous treatment of venous malformations (VM).
  
  
  METHODS
  In this prospective, non-randomized multicenter study patients with clinically and by magnetic resonance imaging diagnosed VM were treated. Efficacy and safety of the gel was evaluated. Therapeutic outcome was judged at day 56 after the last sclerosing therapy. Blood ethanol levels of ethanol were measured after each infusion. Local and systemic adverse events were recorded.
  
  
  RESULTS
  Seventy-five (75) patients (age 4-46 y, mean 26 y) were treated in 172 sessions. Compared to no treatment, ethanol gel showed a complete cure rate of about 15% per session (p<0.00001). At the end of the last session, therapeutic outcome was complete (score 2) and partial (score 1) in 28 (37%) and 42 patients (56%), respectively, whereas treatment failure (score 0) was observed in 5 patients (7%). The plasmatic ethanol levels were very low (mean±SEM 0.03±0.06 g L(-1)), with only one patient above the legal 0.5 g L(-1) intoxication limit (0.6 g L(-1)). Forty-six (46) product-related adverse events (all local, none systemic) were reported. They included temporary mild isolated pain (N=21), inflammatory reactions (N=4), and local complications (7 skin necroses, 7 compressive neuropathies, 4 product leakage/fistula, 2 intralesional fibrous or granulomatous tissue, 1 dense node; 12.2% of the infusions). All local complications resolved spontaneously, except for 2 skin necroses requesting surgical paring.
  
  
  CONCLUSIONS
  Ethanol gel is an embosclerosing substance that provides high efficiency and improves safety of ethanol in the treatment of VM lesions.
authors: Department of Neuroradiology, University Hospital Freiburg, Breisacher Str. 64, 79106 Freiburg, Germany. martin.schumacher.nrad@uniklinik-freiburg.de
authors: Martin
authors: M
authors: Schumacher
authors: Patrick
authors: P
authors: Dupuy
authors: Jean-Michel
authors: JM
authors: Bartoli
authors: Ulrike
authors: U
authors: Ernemann
authors: Denis
authors: D
authors: Herbreteau
authors: Corinne
authors: C
authors: Ghienne
authors: Laurent
authors: L
authors: Guibaud
authors: Dirk A
authors: DA
authors: Loose
authors: Raul
authors: R
authors: Mattassi
authors: Philippe
authors: P
authors: Petit
authors: Jochen K
authors: JK
authors: Rössler
authors: Francesco
authors: F
authors: Stillo
authors: Johannes
authors: J
authors: Weber
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D000431:Ethanol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D018810:Magnetic Resonance Angiography / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010690:Phlebography / Q000379:methods; D010865:Pilot Projects; D012597:Sclerosing Solutions / Q000627:therapeutic use*; D015911:Sclerotherapy / Q000379:methods*; D016896:Treatment Outcome; D014680:Veins / Q000002:abnormalities*; D055815:Young Adult
chemical_list: D012597:Sclerosing Solutions; D000431:Ethanol