UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023370 |
|---|---|
| Receipt number | R000026910 |
| Scientific Title | A pilot study of a novel threaded fully covered self-expandable metallic stent for unresectable malignant extrahepatic biliary obstruction |
| Date of disclosure of the study information | 2016/07/28 |
| Last modified on | 2020/01/24 21:20:47 |
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Basic information
Public title
A pilot study of a novel threaded fully covered self-expandable metallic stent for unresectable malignant extrahepatic biliary obstruction
Acronym
A pilot study of a novel threaded fully covered self-expandable metallic stent for unresectable malignant extrahepatic biliary obstruction
Scientific Title
A pilot study of a novel threaded fully covered self-expandable metallic stent for unresectable malignant extrahepatic biliary obstruction
Scientific Title:Acronym
A pilot study of a novel threaded fully covered self-expandable metallic stent for unresectable malignant extrahepatic biliary obstruction
Region
| Japan |
Condition
Condition
unresectable malignant extrahepatic biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of a novel threaded fully covered self-expandable metallic stent for unresectable malignant extrahepatic biliary obstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstruction
Key secondary outcomes
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)Patiets with unresectable malignant extrahepatic biliary obstruction
2)Margin of the obstruction at least 10mm below the hilar bifurcation and above the duodenal papilla
3)Written informed consent was obtained
Key exclusion criteria
1)Contraindications of endoscopic procedure
2)Patients with hilar obstruction
3)Patients with periamupullary obstruction
4)Ptients with surgically altered anatomy
5)Patients with severe comorbiditeis in any other organs
6)Patients with performance status 4
7)Pregnant women or those suspected of pregnancy
8)Patients considered ineligible by attending physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadahisa Inoue |
Organization
Aichi Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
tinoue-tag@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahisa Inoue |
Organization
Aichi Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
tinoue-tag@umin.ac.jp
Sponsor or person
Institute
Aichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 28 | 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
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the efficacy and safety of a novel threaded fully covered self expandable metallic stent for unresectable malignant extrahepatic biliary obstruction
Management information
Registered date
| 2016 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026910
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
