Efficacy of the peritoneovenous shunt as palliative care for cancer patients with refractory ascites: a randomized controlled trial (JIVROSG-0803 study)

Background: A randomized, controlled trial to evaluate the superiority of peritoneovenous shunt (PVS) over the other treatments for refractory ascites in advanced cancer patient was conducted. Subjects and methods The subjects were advanced cancer patients with symptoms due to refractory ascites which are difficult to control by medical therapy and cannot be improved by methods other than drainage and with a Palliative Prognostic Index of <6. They were randomly allocated in a 1:1 ratio to receive either PVS placement (test group) or the other treatment (control group). The area under the curve (AUC) of symptom improvement score curve calculated with visual analog scale was compared between the groups as the primary endpoint. The AUC of EQ-5D, SF-8 were also compared between the groups, and adverse events were evaluated with the CTCAE version 3 up to 4 weeks after enrollment or until protocol treatment was discontinued. Results: Forty patients were enrolled between November 2009 and July 2018, with 20 allocated to test group and 20 control group. The mean AUC of the symptom improvement score curves were 133.2 (95% CI: 98.6-167.7) in the test group and 69.9 (95% CI: 34.4-105.4) in the control group (p=0.014). Therefore, the mean AUC was significantly larger in the test group, resulting the primary endpoint was met. There was no significant difference between the groups in SF-8 and EQ-5D. Though some known adverse events were observed, there was no significant difference in the frequency of individual adverse events between the groups. Conclusions: PVS significantly improves the symptom of pain due to refractory ascites compared to other treatments. Although not as effective as improving the comprehensive QOL evaluated with SF-8 and EQ-5D, PVS may be considered the standard of care for advanced cancer patients with refractory ascites.