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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000043
Receipt No. R000000083
Scientific Title A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)
Date of disclosure of the study information 2005/08/06
Last modified on 2010/02/11

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Basic information
Public title A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)
Acronym Comparative study of biliary stent (JIVROSG-0207)
Scientific Title A phase III study of covered versus bare metallic stents for the treatment of malignant bile duct obstruction (JIVROSG-0207)
Scientific Title:Acronym Comparative study of biliary stent (JIVROSG-0207)
Region
Japan

Condition
Condition Malignant common bile duct obstruction
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Breast surgery
Obsterics and gynecology Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical usefulness of covered metallic stents comparing to bare stents in the treatment of malignant common bile duct obstruction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Patency of bile duct at 24 weeks after stent placement.
Key secondary outcomes Technical success rate of tube removal and adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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
Maneuver
Interventions/Control_1 Percutaneous endprosthesis using bare stents.
Interventions/Control_2 Percutaneous endprosthesis using covered stents.
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) Malignant and inoperable common bile duct obstruction.
2) Endoprosthesis completed by a tube.
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
4) Serum bilirubin level not more than 5.0mg/dl.
5) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
6) Expected survival more than 4 weeks.
7) Written informed consent.
Key exclusion criteria 1) Post choledocho-intestinal anatomosis, hepatocellular carcinoma, duodenal cancer, peritoneal carcinomatosis, mucin-producing tumor.
2) Duodenal or intestinal obstruction.
3) Biliary infection.
4) Pregnancy.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Yoshioka
Organization Nara Prefectural Nara Hospital
Division name Department of Radiology
Zip code
Address 1-30-1, Hiramatsu, Nara 631-0846, Japan
TEL 0742-46-6001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Arai
Organization JIVROSG, Coordinating Office
Division name Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL http://jivrosg.umin.jp/
Email jivrosgoffice@ml.res.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
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 06 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No significant difference of the patency of bile duct between bare stent group and covered stent group at 24 weeks after stent placement.
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 Completed
Date of protocol fixation
2002 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2003 Year 02 Month 01 Day
Last follow-up date
2006 Year 10 Month 01 Day
Date of closure to data entry
2006 Year 12 Month 01 Day
Date trial data considered complete
2006 Year 12 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 06 Day
Last modified on
2010 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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