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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010782
Receipt No. R000012474
Scientific Title Efficacy of covered stent for palliation of malignant gastroduodenal obstruction
Date of disclosure of the study information 2013/06/01
Last modified on 2017/11/29

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Basic information
Public title Efficacy of covered stent for palliation of malignant gastroduodenal obstruction
Acronym Covered SEMS for GOO
Scientific Title Efficacy of covered stent for palliation of malignant gastroduodenal obstruction
Scientific Title:Acronym Covered SEMS for GOO
Region
Japan

Condition
Condition Gastric outlet obstruction caused by unresectable neoplasms
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of covered SEMS in reducing stent obstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stent patency
Key secondary outcomes (1) success rate
(2) complication

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) Unresectable malignant gastric outlet obstrcution
(2) Performance score (ECOG) 0-3
(3) Acquisition of written informed consent
(4) The age of 20 years or older
Key exclusion criteria GI perforation
Target sample size 20

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 and Hepatology, Department of Internal Medicine
Zip code
Address 2-17-6 Ohashi Meguro-ku Tokyo, Japan
TEL 03-3468-1251
Email maetani-gi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Iruru Maetani
Organization Toho University Ohashi Medical Center
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 2-17-6 Ohashi Meguro-ku Tokyo, Japan
TEL 03-3468-1251
Homepage URL
Email maetani-gi@umin.ac.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine
Toho Univeristy 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
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
2013 Year 06 Month 01 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
2012 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2013 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 Prospective study

Management information
Registered date
2013 Year 05 Month 22 Day
Last modified on
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012474

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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