Interventional radiology (Higashimatsuyama-shi (Japan) · 2026
Efficacy of the Peritoneovenous Shunt as Palliative Care for Patients with Advanced Cancer with Refractory Ascites: A Randomized Controlled Trial (JIVROSG-0803 Study).
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Arai Yasuaki, Sone Miyuki, Takeuchi Yoshito, Sugawara Shunsuke, Aramaki Takeshi, Tanaka Toshihiro, Sato Mikio, Morita Shinichi
Аннотация
PURPOSE: A randomized controlled trial (UMIN-CTR 000003469) was conducted to evaluate the superiority of peritoneovenous shunt over other treatments for refractory ascites in patients with advanced cancer.
METHODS: The study included patients with advanced cancer with symptoms due to refractory ascites. They were randomly allocated in a 1:1 ratio to receive either peritoneovenous shunt placement (test group) or another treatment (control group). The area under the curve of the symptom improvement score was compared between the groups as the primary endpoint. The areas under the curve of the EuroQol 5-Dimension and 8-Item Short Form Health Survey were also compared between the groups, and adverse events were evaluated up to 4 weeks after enrollment or until the protocol treatment was discontinued.
RESULTS: Forty patients (test group, 20; control group, 20) were enrolled between November 2009 and July 2018. The mean areas under the curve of the symptom improvement score curves were 133.2 (95% confidence interval: 98.6-167.7) and 69.9 (95% confidence interval: 34.4-105.4) in the test and control groups, respectively. The mean area under the curve was significantly larger in the test group than in the control group, and the primary endpoint was met. No significant differences were observed between the groups in the 8-Item Short Form Health Survey and EuroQol 5-Dimension scores or the frequency of adverse events.
CONCLUSIONS: Peritoneovenous shunt hunt significantly improved the symptoms due to refractory ascites compared with other treatments. Although it was not significantly more effective for improving the comprehensive quality of life evaluated with the 8-Item Short Form Health Survey and EuroQol 5-Dimension, peritoneovenous shunt may be considered the standard of care for patients with advanced cancer and refractory ascites.
METHODS: The study included patients with advanced cancer with symptoms due to refractory ascites. They were randomly allocated in a 1:1 ratio to receive either peritoneovenous shunt placement (test group) or another treatment (control group). The area under the curve of the symptom improvement score was compared between the groups as the primary endpoint. The areas under the curve of the EuroQol 5-Dimension and 8-Item Short Form Health Survey were also compared between the groups, and adverse events were evaluated up to 4 weeks after enrollment or until the protocol treatment was discontinued.
RESULTS: Forty patients (test group, 20; control group, 20) were enrolled between November 2009 and July 2018. The mean areas under the curve of the symptom improvement score curves were 133.2 (95% confidence interval: 98.6-167.7) and 69.9 (95% confidence interval: 34.4-105.4) in the test and control groups, respectively. The mean area under the curve was significantly larger in the test group than in the control group, and the primary endpoint was met. No significant differences were observed between the groups in the 8-Item Short Form Health Survey and EuroQol 5-Dimension scores or the frequency of adverse events.
CONCLUSIONS: Peritoneovenous shunt hunt significantly improved the symptoms due to refractory ascites compared with other treatments. Although it was not significantly more effective for improving the comprehensive quality of life evaluated with the 8-Item Short Form Health Survey and EuroQol 5-Dimension, peritoneovenous shunt may be considered the standard of care for patients with advanced cancer and refractory ascites.