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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023315
Receipt No. 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

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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
Email 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
Email kousukeminaga@med.kindai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026864

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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