UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014322 |
|---|---|
| Receipt number | R000015494 |
| Scientific Title | Feasibility study of endoscopic ultrasound-guided biliary drainage(EUS-BD) for malignant biliary obstruction. |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/06/19 21:56:55 |
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Basic information
Public title
Feasibility study of endoscopic ultrasound-guided biliary drainage(EUS-BD) for malignant biliary obstruction.
Acronym
N-EUS-BD trial
Scientific Title
Feasibility study of endoscopic ultrasound-guided biliary drainage(EUS-BD) for malignant biliary obstruction.
Scientific Title:Acronym
N-EUS-BD trial
Region
| Japan |
Condition
Condition
Patients with unresectable malignant biliary obstruction for whom ERCP had been failed.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and Safety of EUS-BD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
technical and clinical success rate
Key secondary outcomes
patients' QoL, incidence of complication, stent dysfunction rate, time to stent dysfunction, overall survival
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)Biliary drainage required for biliary obstruction caused by unresectable malignant tumors
2)Failure to perform biliary drainage by ERCP
3)Maintained major organ function
4)Performance status 0-2
5)Informed consent provided by the patients
6)Predictive survival>=3 months
Key exclusion criteria
1)Difficult to insert the endoscope
2)Severe coagulation dysfunction
3)Pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eizaburo Ohno |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
Homepage URL
eono@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint : success rate of EUS-BD
Secondary endopoints:
patienst's QoL(questionnaire)
rate of complication
time to stent dysfunction
patient suvival
Management information
Registered date
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2014 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015494
