UMIN-CTR Clinical Trial

Basic information
Public title	Development of endoscopic nasal biliary drainage tube alterable to internal drainage
Acronym	Development of ENBD alterable to internal drainage
Scientific Title	Development of endoscopic nasal biliary drainage tube alterable to internal drainage
Scientific Title:Acronym	Development of ENBD alterable to internal drainage
Region	Japan

Condition
Condition	Patients who need both detailed image and continuous drainage of biliary tract
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Development ofa novel ENBD alterable to internal drainage
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate
Key secondary outcomes	complication

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who need both detailed image and continuous drainage of biliary tract
Key exclusion criteria	1.Cases having difficulty in endoscopic approach 2.Cases with sever complication in other organs 3.Cases judged by principal investigator to be inadequate as subjects
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Mori
Organization	Ichnomiya Nishi Hospital
Division name	Gastroenterology
Zip code	4940001
Address	1 Hira Kaimei Ichinomiya Aichi Japan
TEL	0586-48-0077
Email	a-mori@anzu.or.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Mori
Organization	Ichnomiya Nishi Hospital
Division name	Gastroenterology
Zip code	4940001
Address	1 Hira Kaimei Ichinomiya Aichi Japan
TEL	0586-48-0077
Homepage URL	http://www.anzu.or.jp
Email	a-mori@anzu.or.jp

Sponsor
Institute	Department of the gastroenterology, Ichnomiya Nishi Hospital
Institute
Department

Funding Source
Organization	Department of the gastroenterology, Ichnomiya Nishi Hospital
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	Ichinomiya Nishi Hospital
Address	1 Hira Kaimei
Tel	0586480077
Email	a-mori@anzu.or.jp

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	2015 Year 01 Month 30 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	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 30 Day
Date of IRB	2015 Year 01 Month 30 Day
Anticipated trial start date	2015 Year 01 Month 30 Day
Last follow-up date	2020 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We developed the device of the ERCP-related procedure and evaluated the utility in daily ERCP

Management information
Registered date	2015 Year 01 Month 30 Day
Last modified on	2020 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019037