UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of metallic stent for benign biliary stricture.
Acronym	Efficacy of metallic stent for benign biliary stricture.
Scientific Title	Efficacy of metallic stent for benign biliary stricture.
Scientific Title:Acronym	Efficacy of metallic stent for benign biliary stricture.
Region	Japan

Condition
Condition	Benign biliary stricture
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the long-term efficacy and safty of matallic stent for benign biliary stricture requiring drainage.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	time of stent patency
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	biliary metallic 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) Patients' age of more than 20 years-old. 2) Patients having biliary stricture requiring drainage caused by benign diseases as follow; chronic pancreatitis, autoimmune pancreatitis, inflammatory stricture, stricture of anastomosis after liver or bile duct resection including liver transplantation, biliary injury caused by surgical procedure, sclerosing cholangitis and lower biliary stricture caused by duodenal papillitis. 3) Patients having cholangitis, obstructive jaundice and liver dysfunction caused by benign biliary stricture. 4) Written informed consent is obtained from patient before the study.
Key exclusion criteria	1) Patients' age of less than 20 years-old. 2)Written informed consent is not obtained from patient before the study. 3) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takamitsu Middle name Last name Sato
Organization	Yokohama city university hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL	+81-45-787-2640
Email	tasatou-ykh@umin.ac.jp

Public contact
Name of contact person	1st name Takamitsu Middle name Last name Sato
Organization	Yokohama city university hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL	+81-45-787-2640
Homepage URL
Email	tasatou-ykh@umin.ac.jp

Sponsor
Institute	Yokohama city university hospital, Department of Gastroenterology and Hepatology.
Institute
Department

Funding Source
Organization	Yokohama city university 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	Yokohama city university hospital
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
Tel	045-787-2714
Email	chiken@yokohama-cu.ac.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 10 Month 07 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	2015 Year 09 Month 17 Day
Date of IRB	2015 Year 09 Month 17 Day
Anticipated trial start date	2015 Year 10 Month 06 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 07 Day
Last modified on	2022 Year 04 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022266