UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016252
Receipt number R000015527
Scientific Title A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors
Date of disclosure of the study information 2015/01/23
Last modified on 2015/01/18 13:43:14

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Basic information

Public title

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Acronym

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Scientific Title

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Scientific Title:Acronym

A multicenter prospective study on the usefulness of metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Region

Japan


Condition

Condition

Middle-lower bile duct obstruction caused by malignant tumors such as pancreas cancer,papilla Vater cancer,bile duct cancer,gallbladder cancer,malignant lymphoma,lymph node metastasis,etc

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Investigate of the usefulness of metallic stents with long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Duration until stent dysfunction

Key secondary outcomes

Overall survival, Kinds and frequency of the complication, A effective rate of the stent in the time of death


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We will place metallic stents of long covers for biliary obstruction caused by unresectable middle-lower bile duct malignant tumors into the obstructive portion and research duration until stent dysfunction,overall survival,the kinds and frequency of the complication,the effective rate of the stent in the time of death.
Reseach period; Up to the day passed 12 months from the day started to follow the last registrant(30th case).

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.Cases of biliary obstruction caused by middle-lower bile duct malignant tumors
2.As a general rule, cases in which a pathological definitive diagnosis was obtained (regardless of whether they were cases of cytodiagnosis or histological diagnosis). In addition, even if, for some reason or other, a pathological definitive diagnosis was not obtained, cases in which a clear diagnosis was obtained through such means as clinical findings, tumor markers, US, CT, MRI, etc. were also used as subjects for investigation.
3.Cases for which no plans have been made for carrying out radical resection.
4.Concerning participation in the study, patients who provide informed consent (as a general rule, the patients must be carried out of cancer notification).

Key exclusion criteria

1.Cases in which informed consent cannot be obtained
2. Cases in which there was poor first biliary tract drainage
3.Others, including cases in which the principal investigator (or sub-investigator) in the study judges the patient to be unsuitable as a subject for the investigation such as cases of severe dysfunction of the cardiopulmonary performance, dementia, etc.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuo Tokuhara

Organization

Daito-central hospital

Division name

internal medicine department

Zip code


Address

2-1-11 Ono,Daito-shi,Osaka,Japan

TEL

072-870-0200

Email

tokuman.am@wing.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuo Tokuhara

Organization

Daito-central hospital

Division name

internal medicine department

Zip code


Address

2-1-11 Ono,Daito-shi,Osaka,Japan

TEL

072-870-0200

Homepage URL


Email

tokuman.am@wing.ocn.ne.jp


Sponsor or person

Institute

Daito-central hospital

Institute

Department

Personal name



Funding Source

Organization

Daito-central hospital

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

2015 Year 01 Month 23 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

Preinitiation

Date of protocol fixation

2015 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 01 Month 18 Day

Last modified on

2015 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015527


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name