UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010244
Receipt number R000011915
Scientific Title A retrospective study to evaluate safety and utility of a newly designed large cell stent for endoscopic bilateral stent-in-stent placement in patients with malignant hilar biliary obstruction
Date of disclosure of the study information 2013/03/14
Last modified on 2013/09/16 21:54:35

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Basic information

Public title

A retrospective study to evaluate safety and utility of a newly designed large cell stent for endoscopic bilateral stent-in-stent placement in patients with malignant hilar biliary obstruction

Acronym

A newly designed large cell stent for endoscopic bilateral stent-in-stent placement

Scientific Title

A retrospective study to evaluate safety and utility of a newly designed large cell stent for endoscopic bilateral stent-in-stent placement in patients with malignant hilar biliary obstruction

Scientific Title:Acronym

A newly designed large cell stent for endoscopic bilateral stent-in-stent placement

Region

Japan


Condition

Condition

Nonresectable malignant hilar biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate an efficacy and safety of bilateral stent-in-stent placement

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Technical success rate of bilateral stent-in-stent 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Nonresectable malignant hilar biliary obstruction

Key exclusion criteria

1, Post hepatctomy
2, Severe ipisilateral hepatic atrophy
3, Advanced biliary stricture beyond the third branch

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazumichi Kawakubo

Organization

Hokkaido University Graduate School of Medicine

Division name

Deparment of Gastroenterology and Hepatology

Zip code


Address

Kita15 Nishi7, Kita-ku, Sapporo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Hokkaido University Hospital

Division name

Institutional Review Board

Zip code


Address


TEL


Homepage URL


Email

crjimu@huhp.hokudai.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology, Hokkaido University Hospital

Institute

Department

Personal name



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)



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

2013 Year 03 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2013 Year 06 Month 30 Day


Other

Other related information

Retrospective analysis


Management information

Registered date

2013 Year 03 Month 14 Day

Last modified on

2013 Year 09 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011915


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name