UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004587 |
|---|---|
| Receipt number | R000005480 |
| Scientific Title | Inside-stent placement for malignant hilar obstruction |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2011/09/27 11:43:57 |
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Basic information
Public title
Inside-stent placement for malignant hilar obstruction
Acronym
Inside-stent study
Scientific Title
Inside-stent placement for malignant hilar obstruction
Scientific Title:Acronym
Inside-stent study
Region
| Japan |
Condition
Condition
Malignant hilar obstruction
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of inside-stent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The patency of inside stent.
Key secondary outcomes
Complications, Technically success rates, Laboratory datas.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inside-stent placement for malignant hilar obstruction
Interventions/Control_2
Plastic stent placement for malignant hilar obstruction with conventional method
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Malignant hilar obstruction without indication for operation.
ECOG Performance Status is 0-3.
KPS>60%.
Key exclusion criteria
Papillary tumor.
Post operative stomach.
Previously received sphincterotomy.
General condition is severe.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuzo Kodama |
Organization
Kyoto University Hospital
Division name
Department of gastroenterology and hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4319
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kurita |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of gastroenterology and hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4319
Homepage URL
akurita@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 19 | Day |
Last modified on
| 2011 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005480
