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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012784
Receipt No. R000014935
Scientific Title Gastroduodenal stenting with a low axial force stent: long-term benefits and additional stent intervention
Date of disclosure of the study information 2014/01/07
Last modified on 2014/01/15

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Basic information
Public title Gastroduodenal stenting with a low axial force stent: long-term benefits and additional stent intervention
Acronym Gastroduodenal stenting with a low axial force stent: long-term benefits and additional stent intervention
Scientific Title Gastroduodenal stenting with a low axial force stent: long-term benefits and additional stent intervention
Scientific Title:Acronym Gastroduodenal stenting with a low axial force stent: long-term benefits and additional stent intervention
Region
Japan

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

Objectives
Narrative objectives1 Estimating first and additional gastroduodenal stent interventions retrospectively, this study aimed to determine the feasibility and efficacy for long-term palliation of malignant GOO using low axial force stents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The long-term improvement in oral intake.
Key secondary outcomes 1) The feasibility and safety of additional stent interventions.
2) The factors related to poor effectiveness.

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 All patients with gastroduodenal stenosis secondary to malignancy.
Key exclusion criteria Patients who had been treated with stents other than Niti-S, who had undergone surgical resection of the stomach or duodenum, and who had multiple levels of obstruction in the intestinal tract.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamitsu Sato
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan.
TEL +81-52-762-6111
Email tsato@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamitsu Sato
Organization Aichi Cancer Center Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan.
TEL +81-52-762-6111
Homepage URL
Email tsato@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama City University School of Medicine
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
2014 Year 01 Month 07 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
2013 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Estimating first and additional gastroduodenal stent interventions retrospectively, this study aimed to determine the feasibility and efficacy for long-term palliation of malignant GOO using low axial force stents.

Management information
Registered date
2014 Year 01 Month 07 Day
Last modified on
2014 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014935

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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