UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007580 |
|---|---|
| Receipt number | R000007981 |
| Scientific Title | Covered versus uncovered self-expandable metallic stents in the palliative treatment of malignant gastroduodenal obstruction: a randomized, multicenter study. |
| Date of disclosure of the study information | 2012/03/27 |
| Last modified on | 2013/05/08 10:55:15 |
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Basic information
Public title
Covered versus uncovered self-expandable metallic stents in the palliative treatment of malignant gastroduodenal obstruction: a randomized, multicenter study.
Acronym
Comparison of covered vs. uncovered SEMS in gastroduodenal stenting
Scientific Title
Covered versus uncovered self-expandable metallic stents in the palliative treatment of malignant gastroduodenal obstruction: a randomized, multicenter study.
Scientific Title:Acronym
Comparison of covered vs. uncovered SEMS in gastroduodenal stenting
Region
| Japan |
Condition
Condition
Unresectable malignant gastric outlet obstruction
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the clinical outcomes of covered and uncovered SEMSs for the palliation of
malignant gastroduodenal obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency
Key secondary outcomes
1) Technical and clinical success
2) Complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Covered SEMS
Interventions/Control_2
Uncovered SEMS
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) Documented malignant obstructions of the pylorus and/or duodenum caused by unresectable tumors.
(2) Obtained informed consent.
Key exclusion criteria
(1) Evidence of gastrointestinal perforation.
(2) The documentation of multiple distal obstructions.
(3) Not obtained informed consent.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iruru Maetani |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Toho University Ohashi Medical Center
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
2-17-6 Ohashi Meguro-ku Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Toho University 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
National Hospital Organization Kyoto Medical Center
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
| 2012 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | 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
| 2012 | Year | 03 | Month | 27 | Day |
Last modified on
| 2013 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007981
