UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023315 |
|---|---|
| Receipt number | R000026864 |
| Scientific Title | Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage using a newly developed stent with a small diameter delivery system in patients with unresectable malignant distal biliary obstruction: a prospective multicenter registration study. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/09/05 21:15:37 |
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Basic information
Public title
Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage using a newly developed stent with a small diameter delivery system in patients with unresectable malignant distal biliary obstruction: a prospective multicenter registration study.
Acronym
Evaluation of the efficacy of EUS-BD in patients with unresectable malignant distal biliary obstruction
Scientific Title
Evaluation of the efficacy of endoscopic ultrasound-guided bile duct drainage using a newly developed stent with a small diameter delivery system in patients with unresectable malignant distal biliary obstruction: a prospective multicenter registration study.
Scientific Title:Acronym
Evaluation of the efficacy of EUS-BD in patients with unresectable malignant distal biliary obstruction
Region
| Japan |
Condition
Condition
Cases with unresectable malignant distal biliary obstruction after failed initial ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic ultrasound-guided biliary drainage using a newly designed metallic stent in patients with unresectable malignant distal biliary obstruction after failed ERCP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success rate of endoscopic ultrasound-guided biliary drainage using a newly designed metallic stent
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)Patients with unresectable malignant distal biliary obstruction after failed ERCP
2)Patients consent to be included in this study based on his/her own free will after sufficient informing and understanding of the study
Key exclusion criteria
1)Patients who cannot undergo endoscopic procedures
2)Patients whose performance status are 4
3)Patients with sever complication in other organs except original disease
4)Patients whose life prognosis are expected shorter than 3 months
5)Cases judged by principal investigator to be unsuitable as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Minaga |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
kousukeminaga@med.kindai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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 | 09 | Month | 01 | 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
| 2016 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study (cohort study)
This study aims to evaluate the efficacy and safety of endoscopic-ultrasound guided biliary drainage (EUS-BD) using a newly designed metallic stent in patients with malignant distal biliary obstruction after failed ERCP
The primary outcome is the clinical success rate of EUS-BD. The secondary outcomes are technical success rate, procedure time, adverse events, and stent patency 3 months after EUS-BD.
The target of this study is a patient with unresectable distal biliary obstruction after failed ERCP visited participating institutions between 2016 July and 2017 July.
Management information
Registered date
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2016 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026864
