UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023938 |
|---|---|
| Receipt number | R000027448 |
| Scientific Title | Evaluation of endoscopic ultrasonography-guided biliary drainage (EUS-BD) using metallic stent of small diameter delivery system in patients with distal biliary obstruction due to unresectalbe malignant tumors:a randomized multicenter study. |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2019/02/26 20:19:11 |
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Basic information
Public title
Evaluation of endoscopic ultrasonography-guided biliary drainage (EUS-BD) using metallic stent of small diameter delivery system in patients with distal biliary obstruction due to unresectalbe malignant tumors:a randomized multicenter study.
Acronym
Evaluation of EUS-BD using metallic stent of small diameter delivery system:a randomized multicenter study.
Scientific Title
Evaluation of endoscopic ultrasonography-guided biliary drainage (EUS-BD) using metallic stent of small diameter delivery system in patients with distal biliary obstruction due to unresectalbe malignant tumors:a randomized multicenter study.
Scientific Title:Acronym
Evaluation of EUS-BD using metallic stent of small diameter delivery system:a randomized multicenter study.
Region
| Japan |
Condition
Condition
patients with distal biliary obstruction due to unresectable malignant tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and complications rates of EUS-BD using metallic stent of small diameter delvery sysytem in patients with distal biliary obstruction due to unrectable malignat biliary obstruction after failure of transpapillary drainage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional success rate of EUS-BD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
EUS-BD using metallic stent of small diameter delivery system
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
# Unresectalbe malignant disease
# Malignant bliliary obstrucution to be required biliary drainage
# After unsuccessful ERCP
# Survival expectation for 3 months or longer
Key exclusion criteria
# Inability to perform endoscopy
# performance status=4
# Serious failure of other organs
# Inability to obtaion informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera Wakayama
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Itonaga |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera Wakayama
TEL
073-441-0627
Homepage URL
itonaga@wakayama-med.ac.jp
Sponsor or person
Institute
Reserch and development group in the Japan society ultrasonics in medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan society ultrasonics in medicine
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
近畿大学医学部付属病院（大阪府）、大阪医科薬科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 07 | 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
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 | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027448
