UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Title of the study (Brief title)	The measurement of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Region	Japan

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

Objectives
Narrative objectives1	To measure of the distance between desired position and released position when releasing the self-expandable metallic stent to bile duct.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of accuracy of stent released to the bile duct (distance between desired position and released position)
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Limit of biliary stent
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	1.over 20 years old 2.Diagnosed as malignant disease 3.Case of obstructive jaundice due to distal biliary obstruction 4.Consent has been obtained 5.Surgery was impossible or did not want surgery
Key exclusion criteria	1.Cases where consent is not obtained 2.Serious mental illness 3.Cases with reconstructed intestinal tract 4.Cases with metal allergy 5.Cases judged to be unsuitable for metal stent placement 6.Cases judged inappropriate for other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	Kida Mitsuhiro
Organization	Kitasato University
Division name	gastroenterology
Address	Kitasato,Minami ku,Sagamihara shi,Kanagawa,Japan
TEL	042-778-8111
Email	m-kida@kitasato-u.ac.jp

Public contact
Name of contact person	Hasegawa Rikiya
Organization	Kitasato University
Division name	gastroenterology
Address	Kitasato,Minami-ku,Sagamihara-shi,Kanagawa,Japan
TEL	042-778-8111
Homepage URL
Email	k-r.h@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 05 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 10 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 14 Day
Last modified on	2018 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036712