UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction. A prospective phase II trial.
Title of the study (Brief title)	Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction.
Region	Japan

Condition
Condition	Malignant hilar biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficancy and safety of plastic stent placement above the sphincter of Oddi for patients of malignant hilar biliary obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to dysfunction
Key secondary outcomes	1.Dysfunction rate and substance 2.Complication rate and substance 3.Suvival time 4.Re-intervention rate and method 5.Operation time 6.success rate of operation

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	Maneuver
Interventions/Control_1	A plastic stent which is attached a nylon string is used. The plastic stent is placed endoscopically above the sphincter of Oddi for malignant hilar biliary obstruction.
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.Unresectable malignant hilar biliary obstruction is proven by pathological or radiological diagnosis. 2.A stent placement is needed. 3.The therapy of a stent placement have never been performed. 4.Endoscopic stenting can be performed. 5.A stent can be placed above the sphincter of Oddi. 6.Written informed concent of the print.
Key exclusion criteria	1.The prognosis is considered within 3 months. 2.They have jaundice which can't be improved by stenting. For example, liver failure. 3.Decision of unsuitableness by principal investigator.
Target sample size	35

Research contact person
Name of lead principal investigator	Kazuya Sugimori
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	ycu.umin@gmail.com

Public contact
Name of contact person	Tomohiro Ishii
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	tishii@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center Gastroenterological Center
Institute
Department

Funding Source
Organization	None
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	横浜市立大学附属市民総合医療センター(神奈川県） 神奈川県立がんセンター（神奈川県） 昭和大学藤が丘病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 11 Month 14 Day
Anticipated trial start date	2011 Year 12 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	2011 Year 11 Month 28 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008023