UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective cohort study for evaluation of efficacy of a newly developed dilator for endosonography-guided biliary drainage
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshihide Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
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	Yoshihide Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023973