UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013155 |
|---|---|
| Receipt number | R000015339 |
| Scientific Title | Utility and safety of duodenal stent for inoperable malignant duodenal stricture : a prospective multicenter study. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/10/22 00:50:57 |
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Basic information
Public title
Utility and safety of duodenal stent for inoperable malignant duodenal stricture : a prospective multicenter study.
Acronym
Utility and safety of duodenal stent
Scientific Title
Utility and safety of duodenal stent for inoperable malignant duodenal stricture : a prospective multicenter study.
Scientific Title:Acronym
Utility and safety of duodenal stent
Region
| Japan |
Condition
Condition
inoperable malignant duodenal stricture
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utlity and safety of duodenal stent for inoperable malignant duodenal stricture
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to stent dysfunction
Key secondary outcomes
risk factors of stent obstruction
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
inoperable malignant duodenal stricture
Key exclusion criteria
PT-INR more than 1.5
PLT less than 50000
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tsuyuguchi |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Medicine and Clinical Oncology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL
043-222-7171
tsuyuguchi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Harutoshi Sugiyama |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Medicine and Clinical Oncology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL
043-222-7171
Homepage URL
sugiharu_food@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine Chiba University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine Chiba University
Organization
Division
Category of Funding Organization
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Time to stent dysfunction, survival time
Management information
Registered date
| 2014 | Year | 02 | Month | 13 | Day |
Last modified on
| 2015 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015339
