Skip to content

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

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)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000040
Enrollment
33
Registered
2005-08-05
Start date
2003-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related refractory ascites

Interventions

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Symptomatic refractory ascites adversely influencing on QOL. 2) Patent superior vena cava and hepatic vein confirmed by CT. 3) Serous ascites. 4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 6) Expected survival over 4 weeks. 7) Written informed consent.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Adverse events

Secondary

MeasureTime frame
Improvement of symptom, decrease of ascites and body weight, elimination of diuretics.

Countries

Japan

Contacts

Public ContactYasuaki Arai

JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital

jivrosgoffice@ml.res.ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026