UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study
Title of the study (Brief title)	Evaluation of efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis: an exploratory study
Region	Japan

Condition
Condition	recurrent benign stricture of choledochojejunal anastomosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of nonflared fully covered metal stent placement in patients with recurrent benign stricture of choledochojejunal anastomosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recurrence rate of stricture after the treatment
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 Maneuver
Interventions/Control_1	period of stent placement: 6 months observation period: more than 1 years after stent removal
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	120 years-old >
Gender	Male and Female
Key inclusion criteria	1) over 20 years old 2) recurrence case after treatment (endoscopic or percutaneous or surgical treatment) 3) patients who need treatment for obstructive jaundice, cholangitis, bile duct stones
Key exclusion criteria	1) Performance status 4 2) previous metal stent placement 3) malignant stricture 4) metal allergy 5) recurrence case of malignant tumor after surgery and life expectancy within 2 years
Target sample size	20

Research contact person
Name of lead principal investigator	Kida Mitsuhiro
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Email	m-kida@kitasato-u.ac.jp

Public contact
Name of contact person	Hiroshi Yamauchi
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	yhiroshi@kitasato-u.ac.jp

Sponsor
Institute	Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 28 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 26 Day
Anticipated trial start date	2016 Year 11 Month 28 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	2016 Year 11 Month 22 Day
Last modified on	2016 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028616