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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028783
Receipt No. 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 2018/11/06

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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
Middle name
Last name Kazuya Sugimori
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan
TEL 045-261-5656
Email sugimori@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruo Miwa
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address Urafune-cho 4-57, Minami-ku, Yokohama, Kanagawa, 232-0024,Japan
TEL 045-261-5656
Homepage URL
Email miwa@yokohama-cu.ac.jp

Sponsor
Institute Yokohama CIty University Medical Center
Institute
Department

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
Email

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
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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
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
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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