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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033599
Receipt No. R000038315
Official scientific title of the study Risk factors of acute cholecystitis after endoscopic covered self-expandable metal stent placement for distal malignant biliary obstruction
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01

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Basic information
Official scientific title of the study Risk factors of acute cholecystitis after endoscopic covered self-expandable metal stent placement for distal malignant biliary obstruction
Title of the study (Brief title) Cholecystitis after endoscopic covered self-expandable metal stent placement for distal malignant biliary obstruction
Region
Japan

Condition
Condition Distal malignant biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To be identified risk factors of acute cholecystitis after covered self-expandable metal stent (SEMS) placement for distal malignant biliary obstruction (MBO).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Risk factors of acute cholecystitis
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent endoscopic covered SEMS placement for distal MBO
Key exclusion criteria Patients with benign biliary stricture
Patients with post cholecystectomy
Patients with the use of SEMS other than WallFlex Biliary RX Fully Covered Stent
Target sample size 90

Research contact person
Name of lead principal investigator Katsuya Kitamura
Organization Showa University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8535
Email k.kitamura@med.showa-u.ac.jp

Public contact
Name of contact person Katsuya Kitamura
Organization Showa University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8535
Homepage URL
Email k.kitamura@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 11 Month 22 Day
Anticipated trial start date
2017 Year 11 Month 22 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 Retrospective study
From January 2014 to September 2017

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038315

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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