UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028783 |
|---|---|
| Receipt number | R000032941 |
| Scientific Title | Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis |
| Date of disclosure of the study information | 2017/08/24 |
| Last modified on | 2020/02/24 00:11:08 |
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Basic information
Public title
Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis
Acronym
Efficacy and safety of duodenal stent
Scientific Title
Efficacy and safety of duodenal stent in patients with gastric outlet obstruction: A multicenter prospective analysis
Scientific Title:Acronym
Efficacy and safety of duodenal stent
Region
| Japan |
Condition
Condition
Gastric outlet obstruction due to malignancy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of duodenal stent for malignant gastric outlet obstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Technical success rate
Safety
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
1. Gastric outlet obstruction due to malignancy
2. Written informed concent of the print.
Key exclusion criteria
1. Case with significantly poor general condition
2. Decision of unsuitableness by principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | azuya Sugimori |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan
TEL
045-261-5656
sugimori@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Haruo |
| Middle name | |
| Last name | Miwa |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan
TEL
045-261-5656
Homepage URL
miwa@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama CIty University 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
Yokohama City University IRB
Address
3-9Fukuura,Kanazawa-ku,Yokohama,Kanagawa
Tel
045-787-2800
nextjim1@yokohama-cu.ac.jp
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
横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
横浜南共済病院(神奈川県)
済生会横浜市南部病院(神奈川県)
藤沢市民病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 24 | 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
31
Results
Clinical success rate 87%
Technical success rate 97%
Results date posted
| 2020 | Year | 02 | Month | 24 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Submitting a paper
Date of the first journal publication of results
Baseline Characteristics
Median age:70
Male 19
Participant flow
Duodenl stenting was performed for 31 cases
Adverse events
Stent migration 1
Cholangitis 1
Delayed perforation 1
Outcome measures
Improvement of GOOSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032941
