UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020772 |
|---|---|
| Receipt number | 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 09:54:33 |
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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
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
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023973
