Abstract No. 190: Phase I/II Study of Transjugular Transhepatic Peritoneal Venous Shunt (TTPVS) for Refractory Ascites (JIVROSG-0201)

Abstract

This multi-center prospective study was conducted to evaluate the safety and efficacy of transjugular transhepatic peritoneal-venous shunt (TTPVS). Patients (pts) had refractory asicites (RA); restricted activities by RA; patent SVC & hepatic veins (HV); clear serous ascites; adequate hematologic, hepatic, renal, cardiac and respiratory functions; 0-3 ECOG performance status (PS); estimated prognosis > 4 wks; written consent. In phases I & II, 9 & 24 pts were enrolled. Adverse events were evaluated by NCI-CTC Ver. 2. Efficacy was classified to SE (significantly effective: improved symptom with body weight decrease to < 95% or girth decrease to < 90% or without medication for > 1 wk), ME (moderately effective: improved symptom without objective findings adjusting SE criteria for > 1 wk) and NE (not effective: not adjusting SE or ME criteria). Response rate was the ratio of pts with SE or ME in total. TTPVS was made by using the same manner as TIPS, perforating from the distal portion of HV to abdominal cavity (AC), placing TTPVS, 10Fr hydrophilic coated catheter with side-holes in its distal and one-way valve side holes (OVSH) in its middle, and adjusting OVSH to the right atrium. The proximal end of TTPVS catheter was capped and fixed with cervical skin by suture. Procedures were completed in all 33 pts (PS 0, 1, 2, 3 in 1, 11, 6, 15 pts). The right HV was used in 32 pts for perforating route. The pressure gradient between SVC and AC was 17 ± 6 cmH2O (mean ± SD). The required time was 53 ± 30 min (mean ± SD). Eight pts died of primary disease progression in 30 days after the procedure. The major adverse reactions (≥ Grade 2) were decreases in serum albumin (n=7) & hemoglobin (n=6). The response rate was 67% (50-80% in 95% CI) (SE, ME, NE in each 11). Seven pts had re-increase of ascites over 10d post procedure presumed to be caused by fibrin sheath formation around the TTPVS catheter. TTPVS is safe and feasible procedure. It can potentially replace the conventional shunt using subcutaneous lager tube to manage RA in cancer pts because of its efficacy and lower invasion. For the better clinical outcomes, the improvement of TTPVS catheter will be required.