UMIN-CTR Clinical Trial

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