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.

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. SUBJECTS AND 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. CONCLUSION 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.