UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012921
Receipt number R000015113
Scientific Title EBD VS EUS-CDS for malignant lower biliary obstructions
Date of disclosure of the study information 2014/01/22
Last modified on 2021/04/17 09:17:09

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Basic information

Public title

EBD VS EUS-CDS for malignant lower biliary obstructions

Acronym

EBD VS EUS-CDS for malignant lower biliary obstructions

Scientific Title

EBD VS EUS-CDS for malignant lower biliary obstructions

Scientific Title:Acronym

EBD VS EUS-CDS for malignant lower biliary obstructions

Region

Japan


Condition

Condition

unresectable malignant lower biliary tract obstractions

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

efficacy of EBD vs CDS

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate and efficacy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

EUS-BD

Interventions/Control_2

EBD

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

1.lower biliary tract obstruction
2. no lesion in the route of EUS-CDS
3. good function of main organs
4. P.S. (ECOG): 0, 1, 2
5. more than 4months survival
6. Informed constent from the patient

Key exclusion criteria

1. pregnant
2. easy bleeding
3. no indications

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Hara

Organization

Aichi Cancer Center Hospital

Division name

gastroenterology

Zip code


Address

1-1 Kanokoden, Tikusa-ku, Nagoya

TEL

+81-52-762-6111

Email

khara@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Hara

Organization

Aichi Cancer Center

Division name

Gastroenterology

Zip code


Address

1-1 Kanokoden, Tikusa-ku, Nagoya

TEL

+81-52-762-6111

Homepage URL


Email

khara@aichi-cc.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Aichi Cancer Center Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hokkaido Univ
Teinekeijinkai Hospital
Osaka medical Univ
Sapporo medical Univ

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

北海道大学
手稲渓仁会病院
大阪医科大学
札幌医科大学


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 22 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

Terminated

Date of protocol fixation

2013 Year 12 Month 13 Day

Date of IRB

2013 Year 11 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 13 Day

Last follow-up date

2021 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 22 Day

Last modified on

2021 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015113


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name