UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040152 |
|---|---|
| Receipt number | R000045782 |
| Scientific Title | Retrospective study of biliary drainage for malignant distal biliary obstruction using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2021/01/09 15:08:44 |
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Basic information
Public title
Retrospective study of biliary drainage for malignant distal biliary obstruction using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Acronym
Retrospective study of DMBO drainage using D-ARMS
Scientific Title
Retrospective study of biliary drainage for malignant distal biliary obstruction using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Scientific Title:Acronym
Retrospective study of DMBO drainage using D-ARMS
Region
| Japan |
Condition
Condition
Patients with malignant distal biliary obstruction using laser-cut fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and safety of biliary stenting using fully-covered self-expandable metal stent with duckbill shaped anti-reflux valve
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success
Key secondary outcomes
Procedural time, Functional success, Adverse event rate, Time to recurrent biliary obstruction
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
1) Distal biliary obstruction which was confirmed with imaging studies
2) Pathological confirmation of malignancy
3) Presence of liver dysfuction, jaundice, or cholangitis due to cholestasis
Key exclusion criteria
1) Surgical altered anatomy with Billroth-II or Roux-en-Y reconstruction
2) Failure to approach the papilla of Vater
3) Absence of hilar biliary obstruction
4) Inappropriate patients to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kin |
| Middle name | |
| Last name | Toshifumi |
Organization
Teine Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
006-8555
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
TEL
011-681-8111
kin_toshifumi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kin |
| Middle name | |
| Last name | Toshifumi |
Organization
Teine Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
006-8555
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido, 006-8555 Japan
TEL
011-681-8111
Homepage URL
kin_toshifumi@yahoo.co.jp
Sponsor or person
Institute
Center for Gastroenterology, Teine-Keijinkai Hospital
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
Department of Gastroenterology and Hepatology, Tokyo Medical University
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teine Keijinkai Hospital
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
Tel
011-681-8111
teine@keijinkai.or.jp
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
手稲渓仁会病院(北海道)
東京医科大学(東京)
久留米大学(福岡)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 02 | 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
Technical success, Procedural time, Functional success, Adverse event rate, Time to recurrent biliary obstruction
Management information
Registered date
| 2020 | Year | 04 | Month | 14 | Day |
Last modified on
| 2021 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045782
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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