UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012784 |
|---|---|
| Receipt number | 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 22:29:40 |
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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
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
tsato@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014935
