UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015093
Receipt number R000017551
Scientific Title Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Date of disclosure of the study information 2014/10/01
Last modified on 2020/01/21 12:31:11

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Basic information

Public title

Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Acronym

Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Scientific Title

Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Scientific Title:Acronym

Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-

Region

Japan


Condition

Condition

unresectable distal biliary obstruction

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy and safety of metallic stent of uncovered metallic stent and covered metallic stent for distal biliary tract obstruction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

stent patency
obstruction rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Uncovered metallic stent

Interventions/Control_2

Covered metallic stent

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. Having lower part biliary tract stenosis in the unresectable malignancy; an adaptation patient of endoscopic retrograde bile duct pancreatic duct contrasting (ERCP).
2. It can be indicated the art of endoscopic duodenal nipple incision and drainage, and an agreement is provided when it enforces it again.
3. When I perform a pathological search and get a malignant definitive diagnosis, or a malignancy is diagnosed by an image and hematologic inspection clinically even if I perform a pathological search when a malignant diagnosis is difficult.
4.Performance status is a patient of 0-2.
5.Having chemoradiation treatment combination or not does not matter.
6.Age is a patient 20 years or older at the agreement acquisition.
7.A document agreement by the free will of the patient person is provided in the one which understands enough it after having received enough explanation on participating of the final examination case 8 within 30th from the first drainage.
9.I am limited to a patient admitted to other Houses after hospitalization or treatment.

Key exclusion criteria

1.The patient who has bile duct stenosis in the liver from a hepatic portal region.
2.A state is extremely bad from head to foot.
3.) not to include the case that removed duodenal confinement by patient (Stent or the operation that duodenal 3rd portion blocked up.
4. The patient who cannot agree to endoscopic retrograde bile duct pancreatic duct contrasting (ERCP) or endoscopic treatment (endoscopic nipple incision, art of drainage).
5.The patient with the allergy to metal.
6.A patient with a history of the custody of the past metallic stent.
7.A patient considered to be below 30 days in convalescence.

Target sample size

98


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Tsuyuguchi

Organization

Chiba University

Division name

Gastroenterology

Zip code


Address

Inohana 1-8-1, Chuou-ku, Chiba City, 260-8670, Japan.

TEL

81-43-2262083

Email

sakai4754@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuji Sakai

Organization

Chiba Univeresity

Division name

Gastroenterology

Zip code


Address

Inohana 1-8-1, Chuou-ku, Chiba City, 260-8670, Japan.

TEL

81-43-2262083

Homepage URL


Email

sakai4754@yahoo.co.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Boston Scientific Japan

Organization

Division

Category of Funding Organization

Profit organization

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

2014 Year 10 Month 01 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

2014 Year 01 Month 01 Day

Date of IRB

2013 Year 12 Month 16 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2020 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 09 Month 09 Day

Last modified on

2020 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017551


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name