UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011335 |
|---|---|
| Receipt number | R000013282 |
| Scientific Title | Efficacy evaluation of a newly-designed partially-covered self-expandable metallic stent for malignant duodenal obstruction |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2018/08/06 16:23:24 |
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Basic information
Public title
Efficacy evaluation of a newly-designed partially-covered self-expandable metallic stent for malignant duodenal obstruction
Acronym
A new partially-covered SEMS for duodenal obstruction
Scientific Title
Efficacy evaluation of a newly-designed partially-covered self-expandable metallic stent for malignant duodenal obstruction
Scientific Title:Acronym
A new partially-covered SEMS for duodenal obstruction
Region
| Japan |
Condition
Condition
Unresectable malignant duodenal obstrucition
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Possible decrease in migration and biliary intervention through the duodenal stent by a new partially-covered SEMS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency
Key secondary outcomes
feasibility; adverse events; possibility of biliary intervention through the stent
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Stent placement with a newly-designed partially-covered SEMS
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
(1)Duodenal obstruction near ampulla
(2)Etiology: unresectable malignancy
(3)Written informed consent
(4)20 year or more
Key exclusion criteria
(1)Multiple obstruction of distal intestine
(2)Gastrointestinal perforation
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iruru Maetani |
Organization
Toho University Ohashi Medical Center
Division name
Divison of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
03-3468-1251
maetani-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iruru Maetani |
Organization
Toho Univerisity Ohashi Medical Center
Division name
Divison of Gastroenterology and
Zip code
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
03-3468-1251
Homepage URL
maetani-gi@umin.ac.jp
Sponsor or person
Institute
Divison of Gastroenterology and Hepatology, Department of Internal Medicine, Toho Univerisity Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 31 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013282
