A phase I/II study of transjugular-transhepatic peritoneo-venous shunting for malignant ascites (JIVROSG-0201) - Transjugular-transhepatic peritoneo-venous shunting for malignant ascites(JIVROSG-0201)

Procedures were completed in all 33 cancer patients (PS 0 in 1, 1 in 11, 2 in 6 and 3 in 15). The right jugular vein was used in 28 pts for the access route, and the right HV was used in 32 pts for perforating route. The pressure gradient between SVC and AC was 17+/-6 cmH2O (mean +/- S.D). The required time was 53+/-30 min (mean +/- S.D). 8 patients died of primary disease progression within 30 days after the procedure. As the procedure related major adverse reaction (>/=Grade 2), decrease of serum albumin, decrease of hemoglobin, appearance of pleural effusion, skin inflammation around the catheter insertion site, congestive cardiac failure, reactive fever were observed in 7,6,3,3,1 and 1 case, respectively. Response rate was 67% (50-80% in 95% CI) (SE in 11, ME in 11 and NE in 11). In 7 among the responded pts, re-increase of ascites occurred over 10 days after the procedure presumed caused by fibrin sheath formation around the TTPVS catheter. Conclusion Newly developed TTPVS is safe and feasible procedure. And it may potentially replace the conventional shunt using subcutaneous lager tube to manage RA in cancer pts because of its lower invasion and efficacy. However, to achieve the better clinical outcome, the improvement of TTPVS catheter will be required.