UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042078 |
|---|---|
| Receipt number | R000034711 |
| Scientific Title | The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study |
| Date of disclosure of the study information | 2020/10/11 |
| Last modified on | 2020/10/11 12:36:58 |
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Basic information
Public title
The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study
Acronym
BULLET trial
Scientific Title
The feasibility of the new designed biliary metallic stent with distal tapering shape for the unresectable distal biliary malignancies: A pilot study
Scientific Title:Acronym
BULLET trial
Region
| Japan |
Condition
Condition
Unresectable distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the patency and safety of newly developed tapered Niti-S stent for distal malignancy biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Stent malfunction and obstruction rate
Stent patency period
Key secondary outcomes
Median survival period
The incidence of adverse event
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 distal biliary malignant obstruction (regardless of primary disease)
2) Never received treatment with SEMS
3) Cases with expected prognosis of more than 2 months
4) 20 years or older
5) Cases with informed consent after sufficient explanation from physician and patient's understanding
6) 2 or less in ECOG performance status
Key exclusion criteria
1) Massive ascites
2) Cases with serious complications in other organs
3) Hilar biliary obstruction
4) Altered anatomy following Billroth-II or Roux-en-Y gastrectomy
5) Case in which ERCP is difficult to perform
6) Duodenal stenosis on the anal side more than the duodenal papilla (cases improved with the duodenal stent can be enrolled)
7) Case in which the physician judged inappropriate for some reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | Shinpei |
Organization
Teikyo University School of medicine University Mizonokuchi Hospital
Division name
Dept of Gastroenterology
Zip code
213-8507
Address
5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa
TEL
044-844-3333
sinpesan@gmail.com
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Shinpei |
Organization
Teikyo University School of medicine University Mizonokuchi Hospital
Division name
Dept of Gastroenterology
Zip code
213-8507
Address
5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa
TEL
044-844-3333
Homepage URL
sinpesan@gmail.com
Sponsor or person
Institute
Dept of Gastroenterology, Teikyo University School of medicine University Mizonokuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept of Gastroenterology, Teikyo University School of medicine University Mizonokuchi Hospital
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
Teikyo University Ethics Committee Secretariat
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.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
帝京大学医学部附属溝口病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034711
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
