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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027737
Receipt No. R000031661
Scientific Title Endoscopic removal of self-expandable metallic stent after placement for the bile duct: a multicenter retrospective large-scale study
Date of disclosure of the study information 2017/06/13
Last modified on 2018/04/30

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Basic information
Public title Endoscopic removal of self-expandable metallic stent after placement for the bile duct: a multicenter retrospective large-scale study
Acronym Salvage study
Scientific Title Endoscopic removal of self-expandable metallic stent after placement for the bile duct: a multicenter retrospective large-scale study
Scientific Title:Acronym Salvage study
Region
Japan

Condition
Condition post self-expandable metallic stent (SEMS) placement
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To retrospectively clarify the efficacy of SEMS extubation after endoscopic placement by analyzing extubation success rate each for stricture site, placement purpose, SEMS types, placement duration, and devices for extubation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SEMS extubation success rate
Key secondary outcomes 1) Difference of extubation success rate according to stricture site.
2) Difference of extubation success rate according to the purpose of SEMS placement.
3) Difference of extubation success rate according to the types of SEMS.
4) Difference of extubation success rate according to the placement duration.
5) Difference of extubation success rate according to the devices used.
6) Complications related to SEMS extubation.

Base
Study type Others,meta-analysis etc

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

Not applicable
Gender Male and Female
Key inclusion criteria Those older than 20 years at the time of SEMS extubation.
Key exclusion criteria 1) Those never admitted or visited to the participating institution.
2) Those refused for study participation.
3) Those considered to be inadequate for inclusion.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIroshi Kawakami
Organization Faculty of Medicine, University of Miyazaki
Division name Department of Gastroenterology and Hepatology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miayzaki 889-1692, Japan
TEL 0985-85-9797
Email hiropon@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Kubota
Organization Faculty of Medicine, University of Miyazaki
Division name Department of Gastroenterology and Hepatology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miayzaki 889-1692, Japan
TEL 0985-85-9797
Homepage URL
Email y_kubota@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Faculty of Medicine, University of Miyazaki
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 Month 13 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 Enrolling by invitation
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information Multicenter retrospective large-scale study

Management information
Registered date
2017 Year 06 Month 13 Day
Last modified on
2018 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031661

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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