UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023938
Receipt No. R000027448
Scientific Title Evaluation of endoscopic ultrasonography-guided biliary drainage (EUS-BD) using metallic stent of small diameter delivery system in patients with distal biliary obstruction due to unresectalbe malignant tumors:a randomized multicenter study.
Date of disclosure of the study information 2016/09/07
Last modified on 2019/02/26

* 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 Evaluation of endoscopic ultrasonography-guided biliary drainage (EUS-BD) using metallic stent of small diameter delivery system in patients with distal biliary obstruction due to unresectalbe malignant tumors:a randomized multicenter study.
Acronym Evaluation of EUS-BD using metallic stent of small diameter delivery system:a randomized multicenter study.
Scientific Title Evaluation of endoscopic ultrasonography-guided biliary drainage (EUS-BD) using metallic stent of small diameter delivery system in patients with distal biliary obstruction due to unresectalbe malignant tumors:a randomized multicenter study.
Scientific Title:Acronym Evaluation of EUS-BD using metallic stent of small diameter delivery system:a randomized multicenter study.
Region
Japan

Condition
Condition patients with distal biliary obstruction due to unresectable malignant tumors
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and complications rates of EUS-BD using metallic stent of small diameter delvery sysytem in patients with distal biliary obstruction due to unrectable malignat biliary obstruction after failure of transpapillary drainage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes functional success rate of EUS-BD
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 EUS-BD using metallic stent of small diameter delivery system
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
120 years-old >
Gender Male and Female
Key inclusion criteria # Unresectalbe malignant disease
# Malignant bliliary obstrucution to be required biliary drainage
# After unsuccessful ERCP
# Survival expectation for 3 months or longer
Key exclusion criteria # Inability to perform endoscopy
# performance status=4
# Serious failure of other organs
# Inability to obtaion informed consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0627
Email kitano@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Itonaga
Organization Wakayama Medical University
Division name Second Department of Internal Medicine
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0627
Homepage URL
Email itonaga@wakayama-med.ac.jp

Sponsor
Institute Reserch and development group in the Japan society ultrasonics in medicine
Institute
Department

Funding Source
Organization The Japan society ultrasonics in medicine
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 近畿大学医学部付属病院(大阪府)、大阪医科薬科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 05 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027448

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.