UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020539 |
|---|---|
| Receipt number | R000023716 |
| Scientific Title | Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2016/08/02 17:12:36 |
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Basic information
Public title
Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction
Acronym
Clinical benefit of Endoscopic Covered Metal Stenting
Scientific Title
Efficacy of Endoscopic Covered Metal Stenting for Malignant Gastric Outlet Obstruction
Scientific Title:Acronym
Clinical benefit of Endoscopic Covered Metal Stenting
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 efficacy and benefit of covered self-expandable metallic stent (C-SEMS) compared with uncovered self-expandable metallic stent(U-SEMS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To claryfy the stent-related predictive factors of poor oral intake.
Key secondary outcomes
Investigate the patient-related redictive factors of poor oral intake.
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
Malignant gastric outlet obstruction (GOO) patients, 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
126
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
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
inaito@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
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
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
| 2016 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/27475489
Number of participants that the trial has enrolled
Results
No significant difference was observed between the U-SEMS and C-SEMS groups with respect to technical success, clinical success, GOO score or time to stent dysfunction. Stent migration was significantly more frequent in patients with C-SEMS. Karnofsky performance status, chemotherapy, peritoneal dissemination, and stent underexpansion were associated significantly with poor GOO score improvement in multivariable analyses, but stent type was not. In subgroup analyses, insufficient stent expansion was an independent factor in patients with U-SEMS, but not in C-SEMS. In the insufficient stent expansion subgroup, C-SEMS was associated significantly with superior clinical improvement compared with U-SEMS. Insufficient stent expansion was observed more frequently in patients with gastrointestinal obstruction due to anastomotic sites or metastatic cancer.
In conclusion, no clinical difference, apart from stent migration, was observed between patients with U-SEMS and C-SEMS. Gastrointestinal obstruction due to an anastomotic site or metastatic cancer may be an indication for C-SEMS use to improve oral intake after SEMS placement.
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
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | 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 paitents who underwent covered metallic stenting for malignant gastric outlet obstruction in affiliated institutions from 2004.
Management information
Registered date
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023716
