UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000043 |
|---|---|
| Receipt number | 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 14:35:42 |
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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 |
| Obstetrics 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
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/
jivrosgoffice@ml.res.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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000083
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| Registered date | File name |
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| Registered date | File name |
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