title: Phase I/II study of transjugular transhepatic peritoneovenous venous shunt, a new procedure to manage refractory ascites in cancer patients: Japan Interventional Radiology in Oncology Study Group 0201.
abstract: OBJECTIVE
  This multicenter phase I/II study evaluated the safety and the efficacy of transjugular transhepatic peritoneovenous shunt (PVS), a new palliative treatment for malignant refractory ascites.
  
  
  METHODS
  Patients with refractory malignant ascites and patent hepatic veins and vena cava were included in this study. Eligible patients underwent the placement of transjugular transhepatic PVS catheter via the jugular vein into the abdominal cavity through the hepatic vein. In phase I, a step-by-step analysis of the safety was performed. The safety and the efficacy were determined through phases I and II.
  
  
  RESULTS
  Thirty-three patients were entered in this study, nine in phase I and 24 in phase II. Transjugular transhepatic PVS was technically successful in all patients. No severe adverse events were observed during the placement procedure. After the placement, 22 adverse events (grade 2 or higher) occurred. Frequent adverse events were hypoalbuminemia (24%) and decrease in hemoglobin (18%), which resolved within 1 week without additional treatment. The clinical efficacy rate at 1 week after the procedure was 67%. Occlusion of the catheter due to fibrin sheath was observed in seven patients, and the revision of the system was performed.
  
  
  CONCLUSIONS
  Transjugular transhepatic PVS is a safe and feasible procedure for managing refractory ascites in patients with cancer. Sufficient efficacy was observed in our initial experience, but a larger clinical trial is warranted.
authors.affiliation: Department of Diagnostic Radiology, National Cancer Center, Tsukiji, Chuo-ku, Tokyo, Japan. arai-y3111@mvh.biglobe.ne.jp
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Arai
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Inaba
authors.forename: Miyuki
authors.initials: M
authors.lastname: Sone
authors.forename: Hiroya
authors.initials: H
authors.lastname: Saitoh
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Yasukazu
authors.initials: Y
authors.lastname: Shioyama
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nakajima
mesh_terms: D000328:Adult; D000368:Aged; D001201:Ascites / Q000209:etiology / Q000473:pathology / Q000601:surgery*; D002406:Catheterization, Peripheral; D015331:Cohort Studies; D005240:Feasibility Studies; D005260:Female; D006503:Hepatic Veins; D006801:Humans; D007564:Japan; D007601:Jugular Veins; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010536:Peritoneovenous Shunt / Q000379:methods*; D015642:Radiology, Interventional; D013812:Therapeutics