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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020772
Receipt No. R000023973
Scientific Title Retrospective cohort study for evaluation of efficacy of a newly developed dilator for endosonography-guided biliary drainage
Date of disclosure of the study information 2016/01/27
Last modified on 2016/07/28

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Basic information
Public title Retrospective cohort study for evaluation of efficacy of a newly developed dilator for endosonography-guided biliary drainage
Acronym ES dilator study
Scientific Title Retrospective cohort study for evaluation of efficacy of a newly developed dilator for endosonography-guided biliary drainage
Scientific Title:Acronym ES dilator study
Region
Japan

Condition
Condition Maligant biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of a newly developed dilator for EUS-guided drainage (ES Dilator)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure time
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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Fourteen consecutive patients who had undergone EUS-guided choledochoduodenostomy (EUS-CDS) with the ES Dilator were identified from a prospectively maintained database (study group ) and 14 other patients who had undergone EUS-CDS without the dilator just prior to its introduction (control group)
Key exclusion criteria None
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
TEL +81(0)22-252-1111
Email yoshi-hk@openhp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
TEL +81(0)22-252-1111
Homepage URL
Email yoshi-hk@openhp.or.jp

Sponsor
Institute Sendai City Medical Center
Institute
Department

Funding Source
Organization Sendai City Medical Center
Organization
Division
Category of Funding Organization Self funding
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 01 Month 27 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 Completed
Date of protocol fixation
2016 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 27 Day
Last follow-up date
2016 Year 02 Month 28 Day
Date of closure to data entry
2016 Year 02 Month 29 Day
Date trial data considered complete
2016 Year 02 Month 29 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information Fourteen consecutive patients who had undergone EUS-CDS utilizing the new dilator for malignant biliary obstruction at Sendai City Medical Center between November 2012 and January 2016 were identified from a prospectively maintained database and enrolled in the study group. Fourteen other consecutive patients who had undergone EUS-CDS without the dilator just prior to its introduction between February 2010 and October 2012 were analyzed as a control group.A historical cohort study was carried out.

Management information
Registered date
2016 Year 01 Month 27 Day
Last modified on
2016 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023973

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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