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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033685
Receipt No. R000038405
Official scientific title of the study Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/08

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Basic information
Official scientific title of the study Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.
Title of the study (Brief title) Multiple SEMSs deployment in hilar obstruction.
Region
Japan

Condition
Condition malignant hilar biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of endoscopic deployment of multiple self-expandable metal stents for unresectable malingant hilar biliary strictures using a combination of side-by-side and stent-in-stent methods.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes technical and clinical success rates.
Key secondary outcomes reinterventions, stent patency, and early and late adverse events.

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria high-grade unresectable malignant hilar biliary stricture (Bismuth classification 3, 4)
Key exclusion criteria resectable malignant hilar biliary stricture
Bismuth classification 1, 2
Performance Status 4
Target sample size 20

Research contact person
Name of lead principal investigator Tatsuya koshitani
Organization Japan Community Healthcare Organization Kobe Central Hospital
Division name Department of Gastroenterology
Address 2-1-1 Soyamacho Kita-ku Kobe, 6511145 Japan.
TEL 078-578-2211
Email tkoshitani@aol.com

Public contact
Name of contact person Tatsuya koshitani
Organization Japan Community Healthcare Organization Kobe Central Hospital
Division name Department of Gastroenterology
Address 2-1-1 Soyamacho Kita-ku Kobe, 6511145 Japan.
TEL 078-578-2211
Homepage URL
Email tkoshitani@aol.com

Sponsor
Institute Japan Community Healthcare Organization Kobe Central Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 08 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 06 Month 01 Day
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038405

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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