UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033685
Receipt number R000038405
Scientific Title Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/08 15:47:16

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Basic information

Public title

Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.

Acronym

Multiple SEMSs deployment in hilar obstruction.

Scientific Title

Endoscopic deployment of multiple self-expandable metal stents for unresectable malignant hilar biliary strictures: a combination of side-by-side and stent-in-stent methods.

Scientific Title:Acronym

Multiple SEMSs deployment in hilar obstruction.

Region

Japan


Condition

Condition

malignant hilar biliary stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of endoscopic deployment of multiple self-expandable metal stents for unresectable malingant hilar biliary strictures using a combination of side-by-side and stent-in-stent methods.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

technical and clinical success rates.

Key secondary outcomes

reinterventions, stent patency, and early and late adverse events.


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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

high-grade unresectable malignant hilar biliary stricture (Bismuth classification 3, 4)

Key exclusion criteria

resectable malignant hilar biliary stricture
Bismuth classification 1, 2
Performance Status 4

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya koshitani

Organization

Japan Community Healthcare Organization Kobe Central Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-1-1 Soyamacho Kita-ku Kobe, 6511145 Japan.

TEL

078-578-2211

Email

tkoshitani@aol.com


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya koshitani

Organization

Japan Community Healthcare Organization Kobe Central Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-1-1 Soyamacho Kita-ku Kobe, 6511145 Japan.

TEL

078-578-2211

Homepage URL


Email

tkoshitani@aol.com


Sponsor or person

Institute

Japan Community Healthcare Organization Kobe Central Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


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

2018 Year 08 Month 08 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

Open public recruiting

Date of protocol fixation

2015 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information

none


Management information

Registered date

2018 Year 08 Month 08 Day

Last modified on

2018 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name