UMIN-CTR Clinical Trial

Basic information
Public title	Risk Factors for Cholecystitis after Placement of Covered Self-Expandable Metallic Stents in Patients with Distal Malignant Biliary Obstructions
Acronym	Risk Factors for Cholecystitis after Placement of Covered SEMS in Patients with Distal Malignant Biliary Obstructions
Scientific Title	Risk Factors for Cholecystitis after Placement of Covered Self-Expandable Metallic Stents in Patients with Distal Malignant Biliary Obstructions
Scientific Title:Acronym	Risk Factors for Cholecystitis after Placement of Covered SEMS in Patients with Distal Malignant Biliary Obstructions
Region	Japan

Condition
Condition	distal malignant biliary obstructions
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the risk factors related to cholecystitis following covered SEMS placement in patients with distal malignant biliary obstructions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	risk factors related to cholecystitis following covered SEMS placement
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 SEMS placement for distal malignant biliary obstructions at the Kitasato University Hospital
Key exclusion criteria	1. history of cholecystectomy 2. biliary drainage using uncovered SEMS 3. patients whom preparatory or concurrent gallbladder drainage placement have performed 4. patients whose participation in the trial was judged to be inappropriate by investigator
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Watanabe
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL	81-42-778-8111
Email	m.wata@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Watanabe
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL	81-42-778-8111
Homepage URL
Email	m.wata@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	institutional ethics committee of Kitasato University Hospital
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa
Tel	+81-42-778-7756
Email	rinri@med.kitasato-u.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 01 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	160
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	Completed
Date of protocol fixation	2018 Year 09 Month 13 Day
Date of IRB	2018 Year 10 Month 10 Day
Anticipated trial start date	2018 Year 10 Month 10 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective trial to investigate the risk factors ralated to cholecystitis following coverd SEMS placement in patients with distal malignant biliary obstructions

Management information
Registered date	2020 Year 04 Month 01 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045632

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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