UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015654 |
|---|---|
| Receipt number | R000018200 |
| Scientific Title | A comparative study of endoscopic ultrasound-guided choledochoduodenostomy and transpapillary stent placement in patients with malignant biliary obstruction as an initial drainage |
| Date of disclosure of the study information | 2014/11/10 |
| Last modified on | 2017/09/12 08:40:31 |
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Basic information
Public title
A comparative study of endoscopic ultrasound-guided choledochoduodenostomy and transpapillary stent placement in patients with malignant biliary obstruction as an initial drainage
Acronym
A comparative study of EUS-CDS and EBS
Scientific Title
A comparative study of endoscopic ultrasound-guided choledochoduodenostomy and transpapillary stent placement in patients with malignant biliary obstruction as an initial drainage
Scientific Title:Acronym
A comparative study of EUS-CDS and EBS
Region
| Japan |
Condition
Condition
Distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success rate, Adverse event rate, Stent dysfunction rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with distal malignant biliary obstruction who underwent EUS-CDS and transpapillary stent placement as a first line treatment
Key exclusion criteria
Patients without clinical data
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo
TEL
0117161161
kkawakubo-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo
TEL
0117162111
Homepage URL
kkawakubo-gi@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
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
| 2014 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/DOI/DOI?10.1055/s-0034-1393179
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
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018200
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
