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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027353
Receipt No. R000030551
Scientific Title Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study
Date of disclosure of the study information 2017/05/16
Last modified on 2019/05/18

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Basic information
Public title Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study
Acronym Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction : A prospective multicenter study(FCAP)
Scientific Title Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study
Scientific Title:Acronym Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction : A prospective multicenter study(FCAP)
Region
Japan

Condition
Condition Unresectable hilar malignant biliary obstruction
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of endoscopic biliary stenting with fully covered self expanding metal stent for unresectable hilar malignant biliary obstruction
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Six month primary patency rate of fully covered self-expandable metal stent
Key secondary outcomes safety, technical success rate, functional success rate, procedure time, stent patency period, cause of stent obstruction, death related endoscopic procedure, re-intervention rate, technical success rate of re-intervention, overall survival time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Placement of fully covered self expanding metal stent for unresectable hilar malignant 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 a) Unresectable hilar malignant biliary obstruction is proven by historical or pathological or radiological diagnosis
b) Obstruction of Bismuth type II or higher and before biliary drainage with metal stent
c) Effective biliary drainage already performed without metal stent
d) Patients of age>=20years
e) Life expectancy>=3months
f) Patients with written informed consent
Key exclusion criteria a) Patients after gastrectomy without Billroth-I reconstruction
b) Patients with pancreatitis
c) Inappropriate patients for entry on this study in the judgement of the investigator
d) Patients who refused to entry this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoshi , Hirotsugu
Middle name
Last name Sugimori, Maruyama
Organization Osaka City University Graduate School of Medicine, Department of Gastroenterology
Division name Gastroenterology
Zip code 5458586
Address 1-5-7, Asahi-chou, Abeno, Osaka, Osaka
TEL 06-6645-3811
Email m1151329@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Yosuke/ Hirotsugu
Middle name
Last name Kinoshita/ Maruyama
Organization Osaka City University Graduate School of Medicine, Department of Gastroenterology
Division name Gastroenterology
Zip code 5458586
Address 1-5-7, Asahi-chou, Abeno, Osaka, Osaka
TEL 06-6645-3811
Homepage URL
Email yousukekino.13@gmail.com

Sponsor
Institute Osaka City University Graduate School of Medicine, Department of Gastroenterology
Institute
Department

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

Other related organizations
Co-sponsor Takarazuka City Hospital, Baba Memorial Hospital, Minamiosaka Hospital, Osaka City General Hospital, Osaka Prefecture Saiseikai Nakatsu Hospital, Ishikiriseiki Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka City University Hospital Certified Review Board
Address 1-2-7-601, asahi-chou, abeno-ku, osaka, Osaka
Tel 06-6645-3456
Email irb@med.osaka-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 大阪市立大学医学部附属病院(大阪府)、宝塚記念病院(大阪府)、馬場記念病院(大阪府)、南大阪病院(大阪府)、大阪市立総合医療センター(大阪府)、大阪府済生会中津病院(大阪府)、医療法人藤井会石切生喜病院(大阪府)  

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 16 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
2017 Year 05 Month 01 Day
Date of IRB
2017 Year 05 Month 01 Day
Anticipated trial start date
2017 Year 05 Month 16 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate efficacy of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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