UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803)
Title of the study (Brief title)	Randomized controlled trial of peritoneovenous shunting
Region	Japan

Condition
Condition	Malignant refractory ascites
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical efficacy of peritoneovenous shunt in patients with refractory ascites comparing with other treatments.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Improvement of the symptoms from ascites.
Key secondary outcomes	Improvement of health-related QOL/ toxicity profile/ survival time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Peritoneovenous shunting (Denver peritoneovenous shunting or transjugular-transhepatic peritoneovenous shunting)
Interventions/Control_2	Any treatments except peritoneovenous shunting
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuaki Arai
Organization	National Cancer Center Hospital
Division name	Department of Diagnostic Radiology
Address	5-1-1,Tsukiji, Chuo-ku,Tokyo,104-0045,Japan
TEL	03-3542-2511
Email	arai-y3111@mvh.biglobe.ne.jp

Public contact
Name of contact person	Miyuki Sone
Organization	National Cancer Center Hospital
Division name	Department of Diagnostic Radiology
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL	03-3542-2511
Homepage URL	http://jivrosg.umin.jp/
Email	msone@ncc.go.jp

Sponsor
Institute	Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	旭川厚生病院（北海道）、手稲渓仁会病院（北海道）、岩手医科大学（岩手県）、栃木県立がんセンター（栃木県）、獨協医大（栃木県）、群馬大学医学部付属病院（群馬県）、防衛医科大学校病院（埼玉県）、国立がんセンター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）、愛知県がんセンター中央病院（愛知県）、三重大学医学部附属病院（三重県）、奈良県立医科大学（奈良県）、高知大学（高知県）、福岡大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 04 Month 13 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2018 Year 09 Month 01 Day
Date of closure to data entry	2018 Year 12 Month 01 Day
Date trial data considered complete	2018 Year 12 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol	http://jivrosg.umin.jp/
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 04 Month 09 Day
Last modified on	2018 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004197