UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010782 |
|---|---|
| Receipt number | 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 16:17:03 |
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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
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
maetani-gi@umin.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Toho Univeristy Ohashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012474
