NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000040

Registered date:05/08/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedCancer-related refractory ascites
Date of first enrollment2003/02/01
Target sample size33
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeAdverse events
Secondary OutcomeImprovement of symptom, decrease of ascites and body weight, elimination of diuretics.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
E-mail jivrosgoffice@ml.res.ncc.go.jp
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
E-mail
Affiliation National Cancer Center Hospital Division of Diagnostic Radiology