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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014322
Receipt No. 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

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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
Email 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
Email eono@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Gastroenterology and Hepatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015494

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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