UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027737
Receipt number 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 2022/06/21 16:57:24

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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 HIroshi
Middle name
Last name Kawakami

Organization

Faculty of Medicine, University of Miyazaki

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

889-1692

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 HIroshi
Middle name
Last name HIroshi Kawakami

Organization

Faculty of Medicine, University of Miyazaki

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

889-1692

Address

5200 Kihara, Kiyotake, Miyazaki, Miayzaki 889-1692, Japan

TEL

0985-85-9797

Homepage URL


Email

hiropon@med.miyazaki-u.ac.jp


Sponsor or person

Institute

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Institute

Department

Personal name



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

University of Miyazaki

Address

5200 Kihara, Kiyotake, Miyazaki, Miayzaki 889-1692, Japan

Tel

0985-85-9010

Email

igakubu_kenkyu@med.miyazaki-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

2017 Year 06 Month 13 Day


Related information

URL releasing protocol

https://miyazaki.bvits.com/rinri/Apply/show.aspx?TYPE=4&ID=5719

Publication of results

Published


Result

URL related to results and publications

https://miyazaki.bvits.com/rinri/Apply/show.aspx?TYPE=4&ID=5719

Number of participants that the trial has enrolled

744

Results

Extubation of metal stent was 95.8% (Fully-cvered type 96.5%; Partially-covered 93.4%; Uncovered type 70%, respectively) .

Results date posted

2022 Year 06 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Number of enrolled patients were 744.

Participant flow

Mutticenter retrospective observational study

Adverse events

10%

Outcome measures

1. The rate of extubation of metal stet
2. Theperiod of stent intubation
3. The length of stricture
4. The time of extubation of metal stent
5. Adverse events

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2012 Year 01 Month 01 Day

Date of IRB

2017 Year 05 Month 08 Day

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

2022 Year 06 Month 21 Day



Link to view the page

Value
https://center6.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