UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030476
Receipt No. R000034562
Scientific Title Usefulness and safety of EUS-BD for malignant bile duct obstruction difficult to treat with ERCP in the community;prospective cohort study
Date of disclosure of the study information 2017/12/20
Last modified on 2019/06/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Usefulness and safety of EUS-BD for malignant bile duct obstruction difficult to treat with ERCP in the community;prospective cohort study
Acronym Usefulness and safety of EUS-BD for cases difficult to treat with ERCP in the community:prospective cohort study
Scientific Title Usefulness and safety of EUS-BD for malignant bile duct obstruction difficult to treat with ERCP in the community;prospective cohort study
Scientific Title:Acronym Usefulness and safety of EUS-BD for cases difficult to treat with ERCP in the community:prospective cohort study
Region
Japan

Condition
Condition Patients with malignant biliary obstruction difficult to treat by ERCP
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 identify the usefulness and safety of EUS-BD regional collaboration system in patients with malignant biliary obstruction who are difficult to treat by ERCP at a regional hospital
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Internal fistula rate of biliary 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 over 20 years old
Cases requiring biliary duct drainage
Cases with biliary obstruction by malignant tumor
Cases in which biliary drainage by ERCP was unsuccessful at regional hospitals
Key exclusion criteria Cases which endoscopes can not be done
Informed consent can not be obtained
Cases scheduled for radical surgery
Cases judged by investigator as inappropriate as subjects
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kitano Masayuki
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code
Address 811-1, Kimiidera, Wakayama city, Wakayama
TEL 073-447-2300
Email kitano@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamura Takashi
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code
Address 811-1, Kimiidera, Wakayama city, Wakayama
TEL 073-447-2300
Homepage URL
Email ttakashi@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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
2017 Year 12 Month 20 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
2017 Year 07 Month 10 Day
Date of IRB
2017 Year 07 Month 10 Day
Anticipated trial start date
2017 Year 07 Month 10 Day
Last follow-up date
2020 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Internal fistulization rate Clinical improvement rate
Treatment time
Frequency of adeverse event
Number of Re-intervention
Procedure success rate
Stent patent duration

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.