UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001708
Receipt number R000002062
Scientific Title Combined endoscopic stent-in-stent placement for malignant biliary and duodenal obstruction using a new duodenal metal stent
Date of disclosure of the study information 2009/02/13
Last modified on 2009/02/13 21:27:44

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Basic information

Public title

Combined endoscopic stent-in-stent placement for malignant biliary and duodenal obstruction using a new duodenal metal stent

Acronym

Enteral metal stent for double stenting malignant bilioduodenal strictures

Scientific Title

Combined endoscopic stent-in-stent placement for malignant biliary and duodenal obstruction using a new duodenal metal stent

Scientific Title:Acronym

Enteral metal stent for double stenting malignant bilioduodenal strictures

Region

Asia(except Japan)


Condition

Condition

malignant bilioduodenal strictures

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility and clinical success rate of endoscopic double stent-in-stent placement using a new duodenal metallic stent for the management of malignant biliary and duodenal obstructions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Technical and clinical success

Key secondary outcomes

complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

endoscopic double stent-in-stent placement

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Unresectable malignant bilioduodenal strictures.
2) Symptoms of biliary and gastric outlet obstruction

Key exclusion criteria

1) Bleeding tendency (INR>1.5, platelet<50,000/ml)

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jong Ho Moon

Organization

Soon Chun Hyang University School of Medicine, Bucheon Hospital

Division name

Digestive Disease Center, Department of Internal Medicine

Zip code


Address

1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea

TEL

+82-32-621-5094

Email



Public contact

Name of contact person

1st name
Middle name
Last name Jong Ho Moon

Organization

Soon Chun Hyang University School of Medicine, Bucheon Hospital

Division name

Digestive Disease Center, Department of Internal Medicine

Zip code


Address

1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea

TEL

+82-32-621-5094

Homepage URL


Email

jhmoon@schbc.ac.kr


Sponsor or person

Institute

Digestive Disease Center, Department of Internal Medicine,
Soon Chun Hyang University School of Medicine, Bucheon, Korea

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Non profit foundation

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

2009 Year 02 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

Completed

Date of protocol fixation

2007 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2008 Year 09 Month 01 Day

Date of closure to data entry

2008 Year 09 Month 01 Day

Date trial data considered complete

2008 Year 09 Month 01 Day

Date analysis concluded

2008 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 02 Month 13 Day

Last modified on

2009 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002062


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name