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Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803)

Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803) - Randomized controlled trial of peritoneovenous shunting

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003469
Enrollment
40
Registered
2010-04-09
Start date
2009-11-01
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

Malignant refractory ascites

Interventions

Peritoneovenous shunting (Denver peritoneovenous shunting or transjugular-transhepatic peritoneovenous shunting) Any treatments except peritoneovenous shunting

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Refractory ascites caused by malignant diseaser 2. Symptomatic ascites refractory to various therapies except paracentesis 3. Palliative prognosis index less than 6. 4. Written informed consent from the patients. 5. Twice measurement of health-related quality-of-life

Exclusion criteria

Exclusion criteria: 1. Non-malignant ascites 2. Previous peritoneovenous shunt 3. More than four weeks after the occurrence of refractory ascites 4. Bloody, mucinous or infectious ascites 5. Malignant peritoneal methothelioma 6. Ascites caused by liver cirrhosis 7. Clinically significant cardiac failure, renal failure, or bleeding tendency 8. Difficulties in the evaluation of quality-of-life 9. Pregnancy 10. Contraindication decided by attending physician

Design outcomes

Primary

MeasureTime frame
Improvement of the symptoms from ascites.

Secondary

MeasureTime frame
Improvement of health-related QOL/ toxicity profile/ survival time.

Countries

Japan

Contacts

Public ContactMiyuki Sone

National Cancer Center Hospital Department of Diagnostic Radiology

msone@ncc.go.jp03-3542-2511

Outcome results

None listed

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