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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007580
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Toho University Ohashi 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 National Hospital Organization Kyoto Medical Center
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007981

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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