UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003469 |
|---|---|
| Receipt number | R000004197 |
| Scientific Title | Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803) |
| Date of disclosure of the study information | 2010/04/09 |
| Last modified on | 2018/10/19 09:52:48 |
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Basic information
Public title
Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803)
Acronym
Randomized controlled trial of peritoneovenous shunting
Scientific Title
Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuaki Arai |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
5-1-1,Tsukiji, Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
arai-y3111@mvh.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Sone |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Homepage URL
http://jivrosg.umin.jp/
msone@ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
http://jivrosg.umin.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2009 | Year | 04 | Month | 13 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004197
