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

UMIN ID: C000000040

Registered date:05/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cancer-related refractory ascites
• Date of first enrollment: 2003/02/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Under local anesthesia, a route from jugular vein reaching to the abdominal cavity through the superior vena cava, hepatic vein and liver parenchymal tissue is made, and then, a transjugular-transhepatic peritoneo-venous shunting catheter is placed.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Improvement of symptom, decrease of ascites and body weight, elimination of diuretics.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Controllable ascites by standard anti-cancer therapies. 2) Intracavitary administration of anti-cancer agent is scheduled. 3) Controllable ascites by vascular interventions. 4) No symptom due to ascites. 5) Ascites due to malignatnt mesothelioma, mucin-producting tumor, pseudomyxoma. 6) Bloody, chylous or cloudy ascites. 7) Tumor or dilated intestine along the planned route for catheterization. 8) Active infection. 9) Untreated esophageal varices with red-color sign. 10) Active bleeding from upper digestive tract. 11) Post hepatic lobectomy. 12) Cardiac pacemaker. 13) Pregnancy.

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare