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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028367
Receipt No. R000032473
Scientific Title Safety and efficacy of self-expandable metallic stents for best supportive care patients
Date of disclosure of the study information 2017/08/01
Last modified on 2018/07/25

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Basic information
Public title Safety and efficacy of self-expandable metallic stents for best supportive care patients
Acronym Metallic stents for best supportive care patients
Scientific Title Safety and efficacy of self-expandable metallic stents for best supportive care patients
Scientific Title:Acronym Metallic stents for best supportive care patients
Region
Japan

Condition
Condition Malignant gastric outlet obstruction (GOO)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical outcomes and adverse events of BSC patients who performed duodenal SEMS placement.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adverse events
Key secondary outcomes technical success, clinical success, median survival time, median stent patency, and required for re-intervention.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria BSC patients with malignant GOO, who consent to participate in the study in Nagoya City University Hospital and research cooperation facilities
Key exclusion criteria Not obtained the consent
Target sample size 208

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuki Hori
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL +81-52-853-8211
Email yhori@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Itaru Naitoh
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL +81-52-853-8211
Homepage URL
Email inaito@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya Daini Red cross Hospital,
Gifu Prefectural Tajimi Hospital,
Kasugai Municipal Hospital,
Nagoya City West Medical Center
Toyokawa City Hospital
Japan Community Health Care Organization
Midori Municipal Hospital
Gamagori City Hospital
Name of secondary funder(s) None

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
2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29725801
Number of participants that the trial has enrolled
Results
uodenal SEMS placement is an effective palliative treatment for malignant GOO in BSC patients. Although the GOO score did not dramatically improve in patients with poor KPS, the procedure was safe and palliatively feasible. Procedure-related pneumonia was fatal; thus, it is essential to proceed with great caution.
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
2004 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 01 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 08 Month 15 Day

Other
Other related information Samples are collected from subjects who participated in this study in Nagoya City University Hospital and research affiliated facilities.
Samples and clinical information without containing personal information are numbered and managed in Nagoya City University Hospital. Consecutive BSC paitents who underwent metallic stenting for malignant GOO in affiliated institutions from 2004.

Management information
Registered date
2017 Year 07 Month 25 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032473

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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